Systems and methods for cutting tissue

Abstract

The elongate electrode is configured to flex and generate plasma to cut tissue. An electrical energy source operably coupled to the electrode is configured to provide electrical energy to the electrode to generate plasma. A tensioning element is operably coupled to the elongate electrode. The tensioning element can be configured to provide tension to the elongate electrode to allow the elongate electrode to flex in response to the elongate electrode engaging tissue and generating plasma. The tensioning element operably coupled to the flexible elongate electrode can allow for the use of small diameter electrodes, such as electrodes having a diameter of 5 pm to 20 pm, which can allow for the formation of narrow incisions, reducing tissue damage. In some embodiments, tensioning of the electrode allows the electrode to more precisely cut tissue by reducing variation in electrode position along a cutting path.

Description

[0001] Related applications

[0002] This application claims the entire disclosure of U.S. Provisional Patent Application No. 62 / 931,226 (titled “SYSTEMS AND METHODS FOR INCISING TISSUE”), filed November 6, 2019, pursuant to 35 USC § 119(e), and U.S. Provisional Patent Application No. 62 / 966,925 (titled “SYSTEM, METHOD, AND APPARATUS FOR CORNEAL RESHAPING BY INTRASTROMAL TISSUEREMOVAL”), filed January 28, 2020, which is incorporated herein by reference.

[0003] The subject matter of this application relates to U.S. Provisional Patent Application No. 62 / 909,092, filed October 1, 2019, entitled “SYSTEMS AND METHODS FOR THE SEMI-AUTOMATED CREATION OF EXTERNALINCISIONS TO REDUCE INTRAOCULAR PRESSURE”, the entire disclosure of which is incorporated herein by reference. background

[0004] Tissue ablation and incisions can be used to perform procedures such as surgical operations in a variety of ways. For example, lasers can be used to correct refractive errors such as myopia, remove cataracts, and treat glaucoma and retinal diseases. Tissue ablation and incisions can also be used in plastic surgery and cardiology for surgical procedures.

[0005] Work relating to this disclosure indicates that the effectiveness and availability of surgical procedures may, at least in some cases, be related to limitations of the devices used to cut and ablate tissue. For example, lasers such as femtosecond lasers can be complex, and treatment may require longer than ideal. Furthermore, at least in some cases, the tissue removal profile along a laser-induced incision may not be as smooth as ideal. In addition, tissue artifacts and debris (such as feathers associated with laser irradiation) can affect the accuracy and effectiveness of ablation and incision during laser treatment.

[0006] While mechanical ablation using blades such as microkeratome blades can be used in certain surgical procedures, work related to this disclosure indicates that mechanical ablation using blades can be less precise and, at least in some cases, may produce a rougher surface than ideal. Although mechanical keratomes have been used to create corneal flaps for procedures such as LASIK, work related to this disclosure indicates that mechanical keratomes may require slightly longer than ideal times, and, at least in some cases, the resulting flaps may be somewhat irregular and rougher than ideal. While two separate flaps within tissue, such as sclera and / or corneal tissue, can be manually removed using a scalpel or diamond blade in conventional tubuloplasty, this can be technique-dependent and difficult for at least some practitioners, potentially leading to postoperative complications. This work will help reduce technique dependence and postoperative complications.

[0007] Although femtosecond lasers have been used to create corneal flaps and pockets, work related to this disclosure indicates that, at least in some cases, the time required for flap and pocket formation can be longer than ideal. Small-Incision Lenticule Extraction (SMILE) is a relatively new corneal reshaping procedure that uses a femtosecond laser system to ablate tissue along the boundaries of a three-dimensional lenticule within the corneal stroma, which can then be removed through a corneal opening. However, work related to this disclosure indicates that, at least in some cases, the three-dimensional lenticule formed and removed using this procedure may not be of the ideal shape. Furthermore, the amount of time required to ablate the tissue defining the lenticule and opening can be longer than ideal.

[0008] While electrodes have been proposed for treating tissue, existing methods can result in more tissue damage and less precise incisions than ideal. Although electrodes that generate plasma have been proposed, these existing methods may not be well-suited for cutting large amounts of tissue, and their accuracy may be less than ideal, at least in some cases.

[0009] In light of the above, improved methods are needed to treat tissue through incisions to mitigate at least some of the aforementioned limitations. Ideally, these methods would reduce complexity and treatment time, provide more precise incisions, and improve outcomes.

[0010] Overview

[0011] Embodiments of this disclosure provide improved methods and systems for cutting tissue. In some embodiments, an elongated electrode is configured to flex and generate plasma to cut tissue. An electrical energy source may be operatively coupled to the electrode and configured to supply electrical energy to the electrode to generate plasma. In some embodiments, a tensioning element is operatively coupled to the elongated electrode. The tensioning element may be configured to provide tension to the elongated electrode to allow the elongated electrode to flex in response to the elongated electrode engaging tissue and generating plasma. In some embodiments, the tensioning element operatively coupled to the flexible elongated electrode allows the use of small-diameter electrodes, such as electrodes with a diameter of 5µm to 20µm, which may allow for the formation of narrow incisions, thereby reducing tissue damage. In some embodiments, electrode tensioning allows the electrode to cut tissue more precisely by reducing changes in electrode position along the cutting path.

[0012] In some embodiments, an elongated electrode is operatively coupled to one or more components to allow tissue resection along a path. The elongated electrode may be coupled to a support structure that moves with the electrode to provide an incision along the path. The support structure may be configured to support one or more arms, such as more than one arm, which support an electrode suspended between the arms. The support structure, the one or more arms, and the elongated electrode may include components of an electrode assembly. The electrode assembly may be operatively coupled to a translational element to provide translational motion to the electrode for cutting tissue. In some embodiments, a contact plate is configured to engage with the tissue prior to cutting with the elongated electrode to shape the tissue, which can provide improved cutting accuracy and shape of the tissue to be removed.

[0013] In some embodiments, a gap extends between a support structure and an electrode suspended between the arms, providing a bidirectional tissue incision and reducing treatment time. In some embodiments, the gap is sized to receive tissue and cut tissue extending into the gap when the support structure and electrode are pulled proximally. In some embodiments, the support structure and electrode are advanced into the tissue to cut the tissue on the first pass with a first incision in the case of a first configuration of one or more contact plates, and the support structure and electrode are pulled proximally to cut the tissue in the case of a second configuration of one or more contact plates. In some embodiments, the second configuration differs from the first configuration, and the tissue cut on the first pass extends into the gap and is cut on the second pass to provide a volume of excised tissue for subsequent removal. In some embodiments, the volume of excised tissue includes a thickness profile corresponding to the difference between a first profile of the first configuration of one or more contact plates and a second profile of the second configuration. In some embodiments, a lens body corresponding to refractive correction of the eye is cut on both the first and second passes, and the lens body can subsequently be removed to provide refractive correction.

[0014] In some embodiments, an elongated electrode is configured to cut tissue such as corneal tissue. An electrical energy source is operatively coupled to the elongated electrode and configured to supply electrical energy to the electrode. A contact plate is configured to engage a portion of tissue, such as corneal tissue, to shape the tissue prior to cutting the cornea with the electrode. A support structure may be operatively coupled to the elongated electrode and the plate, the support being configured to move the electrode relative to the plate and cut the corneal tissue with the electrode.

[0015] By incorporating via reference

[0016] All patents, applications and publications cited and confirmed in this document are incorporated herein by reference, and any citations elsewhere in the application shall be deemed to be incorporated by reference in their entirety. Brief description of the attached diagram

[0017] A better understanding of the features, advantages, and principles of this disclosure will be obtained by referring to the detailed description of the illustrative embodiments set forth below and the accompanying drawings listed below.

[0018] Figure 1A A schematic image of an eye shown in cross-section according to an embodiment of the present disclosure, illustrating the anatomical parts therein.

[0019] Figure 1B A graph showing the relationship between threshold discharge voltage and pulse duration for measurements of negative and positive voltages for a single long and thin electrode according to an embodiment of the present invention.

[0020] Figures 2A to 2F Examples of different conditions encountered under different electrode-to-tissue spacings and / or electrode voltages according to embodiments of the present invention are depicted.

[0021] Figure 3 A graph showing the relationship between the negative threshold voltage and the electrode diameter for measurements of fixed pulses of different durations according to embodiments of the present disclosure.

[0022] Figure 4 and Figure 5 An electrode subsystem for a system for cutting target tissue structures according to embodiments of the present disclosure.

[0023] Figure 6 A system for cutting a target tissue structure according to embodiments of the present disclosure.

[0024] Figure 7 A flowchart illustrating the steps of an implementation method according to embodiments of the present disclosure is provided.

[0025] Figures 8A to 8D A system for cutting target tissue structures according to an embodiment of the present invention.

[0026] Figure 9 A flowchart illustrating the steps of a method according to an embodiment of the present disclosure is provided.

[0027] Figures 10A to 10F A system for cutting a target tissue structure according to an embodiment of the present disclosure.

[0028] Figure 11A and Figure 11B For segmented adjustable contact elements according to embodiments of the present disclosure.

[0029] Figure 12A and Figure 12B For a disc-shaped lens body according to an embodiment of the present disclosure.

[0030] Figures 13 to 15 Different lens configurations according to embodiments of the present disclosure.

[0031] Figure 16A and Figure 16B Histological images of a porcine cornea including a prepared incision, according to an embodiment of the present invention.

[0032] Figure 17 A graph showing the exemplary electrode voltage versus time according to an embodiment of the present disclosure.

[0033] Figure 18 High-speed video images of a cut pig cornea according to embodiments of the present disclosure.

[0034] Figures 19A-19D The aspects of the tissue “lobe” and the tissue “pouch” according to embodiments of the present disclosure are depicted.

[0035] Figure 20 Aspects of a system configured to form a tissue flap or tissue pouch according to embodiments of the present disclosure are described.

[0036] Figure 21 Aspects of a system according to embodiments of the present disclosure are described.

[0037] Figures 22A to 22C A flowchart illustrating the steps of a method according to embodiments of the present disclosure is provided.

[0038] Figure 23 A flowchart illustrating the steps of a method according to embodiments of the present disclosure is provided. Detailed description

[0039] The following detailed description provides a better understanding of the features and advantages of the invention described in this disclosure according to embodiments disclosed herein. Although the detailed description includes many specific embodiments, these are provided by way of example only and should not be construed as limiting the scope of the invention as disclosed herein.

[0040] The disclosed systems and methods are well-suited for integration into existing devices and surgical procedures, such as microkeratomes, which cut tissue to create one or more flaps, bags, or lenses for removal from the tissue, such as SMILE. The disclosed methods and systems are well-suited for integration with lens removal and prostheses, such as removing the lens nucleus and cortex to place an artificial lens. As a non-limiting example, plasma-induced incisions can be formed within the capsule to produce capsulorrhexis. Incisions can be formed within the capsule to create lens fragments or simplify lens fragmentation and / or lens removal. Incisions can be formed in the retina to create bags or flaps. In some embodiments, incisions are formed in the TM to improve drainage and / or reduce intraocular pressure (“IOP”) for the treatment of glaucoma, or incisions are formed in the iris to, for example, produce iridectomy.

[0041] Although incisions in ocular tissues are mentioned, the currently disclosed systems and methods are well-suited for creating incisions in non-ophthalmic surgical procedures such as orthopedic surgery, cardiovascular surgery, neurosurgery, robotic surgery, pulmonary surgery, urological surgery, and soft tissue surgery. While incisions in ocular tissues are mentioned, the currently disclosed methods and systems are well-suited for creating incisions in one or more of collagenous tissue, cartilage, matrix tissue, neural tissue, vascular tissue, muscle, and soft tissues.

[0042] As a non-restrictive example, Figure 1A Various anatomical sites in the eye that may be suitable for practicing this disclosure are shown. The eye includes the cornea, sclera, limbus, sclera, lens capsule, lens, retina, iris, and trabecular meshwork (TM). Although not shown for clarity, Schlemm's canal may be located near the TM. The currently disclosed system can be used to treat any of these sites. In some embodiments, the cornea is shaped to provide refractive treatment of the eye. In some embodiments, the sclera is cut, for example, to provide a filtering bleb for treating glaucoma. In some embodiments, at least a portion of the capsule is cut, for example, to access the cortex and nucleus of the lens. In some embodiments, at least a portion of the lens is cut and excised. In some embodiments, the retina is treated, for example, with electrodes. In some embodiments, the iris is cut with electrodes. In some embodiments, tissues associated with the TM and Schlemm's canal are cut, for example, with reference to glaucoma surgery.

[0043] In some embodiments, applying a sufficient voltage (including periodic or pulsating voltage) to electrodes within or around biological tissue (i.e., the “target tissue structure”) can cause vapor to form near the electrodes. This vapor originates from an initial current and / or electric field established by heating at least one component of the tissue (e.g., water in the tissue) to approximately its vaporization temperature (or “critical temperature,” e.g., ~100°C for pure water at standard pressure). The contents of this vapor chamber can then be ionized by the electrode voltage to destroy (or equivalently “ablate”) at least a portion of the target tissue structure, particularly if the pulse duration of the pulsating voltage waveform is sufficiently short compared to the thermal relaxation time of the target tissue structure, and thermal confinement is achieved, thereby minimizing the amount of residual damaged tissue. The generation of the vapor may be due to a phase change process, so that the accompanying temperature rise can cease once the vaporization temperature is reached via a latent heat process. The volume of the vapor chamber (or equivalently, “bubble”) can increase with increasing vapor volume and, further, can be directly proportional to the electrode voltage and / or current supplied to the tissue by the electrodes as a larger volume of tissue is heated. Similarly, and / or the pressure within the bubble can increase with increasing steam volume, and further, as a larger volume of tissue is heated, can be directly proportional to the electrode voltage and / or current supplied to the tissue by the electrode. Subsequently, if the electrode operates at a sufficiently high voltage such that the electric field strength generated within the steam chamber exceeds a discharge threshold, plasma can be formed within the steam chamber at least partially by ionizing the steam to form plasma-induced ablation, which, when formed along the electrode, can combine to form a plasma-induced incision. As a non-limiting example, the discharge threshold can be selected from: an ionization threshold, an electrical breakdown threshold, a dielectric breakdown threshold, a glow discharge threshold, an ablation threshold, a destruction threshold, and combinations thereof. If the electrode voltage is sufficiently high, the generated electric field strength may allow a secondary discharge and generate an arc. Avoiding such an arc discharge may be advantageous, as will be described elsewhere herein. The plasma can allow current to flow again through the electrode, steam, and tissue, thus potentially leading to a further increase in temperature. The bulk electrode temperature can be proportional to the amount of current flowing through the electrode and / or to surface bombardment by ions and charged particles, chemical reactions, and radiation; it can itself be a function of the amount of plasma generated. Energy can be efficiently delivered to the target tissue structure to achieve thermal confinement within at least a portion of the target tissue structure near the electrode and / or the vapor chamber, to generate and / or maintain the vapor chamber. Thermal confinement can be achieved if the energy is deposited in the target at an energy deposition rate greater than the energy dissipation rate; this can be achieved, for example, when the current flows through the tissue only nominally for a time less than or equal to approximately the thermal time constant of the tissue, for example, using periodic or pulsating voltages.The thermal time constant can be the thermal relaxation time, defined by the size, shape, or geometry of the electrode, the size, shape, or geometry of the vapor chamber, and combinations thereof. The time constant can optionally be defined as the mechanical response time, such as displacement relaxation due to instantaneous deformation of the tissue adjacent to the collapsed vapor chamber. For a semi-infinite material plate, the thermal relaxation time... τ It can be approximated as ,in d It is the distance to enter the organization, and α It is the thermal diffusivity of the tissue. For the sclera and cornea, α Approximately 0.14 mm²•s -1 For example, for a damage range of d = ~2µm, such a thermal relaxation time is... =~28µs. Damage is defined herein as at least partially degenerated tissue or at least partially degenerated tissue components caused by mechanisms that form an incision, such as plasma, heating, etc. Such mechanical response time can be determined by the compressibility and density of the material, which in turn can be related to tissue hydration. For most species, including humans, water may constitute approximately 76% of the corneal stroma by weight.

[0044] In some embodiments, such as those relating to soft tissue, the following relationship can be used to approximate the mechanical properties of the tissue; Where K and G are the bulk modulus and shear modulus, respectively, and ,in β The tissue is compressible, and the average elastic modulus of corneal tissue can range from ~1 MPa to ~3 MPa. Therefore, a sufficiently intense and rapid increase in temperature of the material (i.e., tissue, or a component or part of the tissue) can lead to the vaporization of a certain amount of said material. This vaporization can be an explosive vaporization that destroys the tissue; that is, it leads to tissue “destruction,” also known as tissue “decomposition,” tissue “rupture,” and tissue “ablation.” When operated as described in at least partially compressed materials (such as tissue), the extent of the vapor chamber can intrinsically mediate the plasma discharge process due to the transient mechanical deformation and displacement of said material, since the electric field strength can decrease with the square of the distance from the electrode (e.g., ∝r). -2 And when the bubble grows to the point where the distance from the electrode surface to the bubble surface is too great to be supported by the operating voltage to continue the discharge throughout the vapor chamber (because the electric field strength may decrease accordingly), the discharge may stop. Maintaining glow discharge or disallowing arc discharge may be advantageous for producing precise cuts and minimizing collateral damage. Flashes may accompany plasma. The rate of the flashes may depend on the velocity. The intensity of the flashes may depend on the energy per pulse or the power of the electrodes.

[0045] In some embodiments, the required voltage and associated energy deposition can be reduced by decreasing the width of the electrode, such as... Figure 1B As shown, Figure 1B Containing curve 600; using electrode lengths of ~1mm, ~2mm, ~5mm, and ~10mm corresponding to curves 602, 604, 606, and 608 respectively, the relationship between the negative voltage threshold for tissue vaporization and the diameter of the elongated cylindrical electrode for a ~50µs pulse. Due to the aspect ratio between the width and length of the electrode, such an electrode can be considered an "elongated electrode." That is, an elongated electrode includes a cross-sectional distance significantly smaller than its cut length. This voltage can be kept as low as possible, and can be used for cutting when the voltage exceeds the breakdown threshold without allowing significant thermionic emission, where significant refers to an amount that significantly contributes to thermal damage beyond what would otherwise be present. The electric field around the electrode can be scaled with distance r as follows: ,in E e It is the electric field at the electrode surface and r e That is, the radius of the electrode. Therefore, the difference between the potential on the electrode surface and the potential at a distance R from the nominally cylindrical elongated electrode can be... Therefore, the electric field may be greater than the electrode length. L At a distance from , it becomes nominally spherical, and we can assume that at the ... spherical. L At a considerable distance, the electric potential drops to zero; thus, the potential is generated. In areas with resistivity γ In conductive materials, current density j The power density of the generated Joule heat can be The minimum energy density required to vaporize surface water within a tissue. A may be ,in The liquid layer is in a period of time. τ Temperature rise during the pulse, =~1g / cm 3 It is the density of water, and C = ~4.2 J·g. -1 ·K -1 It is its heat capacity. Therefore, the voltage required for vaporization. U may be This voltage and associated energy deposition can be reduced by decreasing the electrode thickness, i.e., the radius of the aforementioned wire. For a given electrode geometry, the pulse duration... τ It can maintain a thermal relaxation time shorter than that of the target tissue structure. τ r For example, the 1 / e relaxation time of a long cylinder can be... ,in It is the thermal diffusivity of the material, and K This refers to thermal conductivity. For a pure tungsten wire electrode with a diameter of 20µm, it may produce a conductivity of ~65µs. τ r Or, for an equivalent cylinder of water or tissue, approximately 1 / 5 of its volume, such as... α 钨 =~0.66mm 2 •s -1 and α 组织 =~0.14mm 2 •s -1 These curves suggest that for wire electrodes with a length of ~10 mm and a diameter of less than ~30 µm, a negative voltage of ~-200 V may be suitable for cutting the target tissue structure while maintaining a margin of ~200 V between the positive breakdown threshold, as will be described elsewhere in this document.

[0046] In some embodiments, the discharge can begin with the vaporization of tissue surrounding the electrode and can continue if the voltage is high enough to bridge the vapor gap filled with ionized gas between the electrode and the tissue. If the voltage is insufficient to maintain such a vapor chamber along the entire length of the electrode, a liquid may come into contact with the electrode, allowing current to pass through the interface. The depth of heating may be proportional to the length of the liquid-electrode interface. Thus, for an otherwise stationary system, the extent of the damaged zone may increase as the voltage decreases. Higher voltages can correct for this, but if the voltage exceeds both the negative and positive plasma thresholds, the electrode may become too hot, and the plasma discharge may become self-sustaining, as referenced. Figure 3 As described elsewhere, thermionic emission can be avoided to limit collateral damage to tissue. Turbulence can break up the vapor chamber, potentially damaging both the electrode and the tissue. The electrode can be so thin that a small voltage can support the vapor chamber, and said voltage can be slightly above the plasma threshold. At voltages below any plasma threshold, a vapor chamber of small thickness can be maintained around at least a portion of the electrode. Translating the electrode allows for small-area contact with the tissue and can be conceptualized as single-point or point-like contact. Such point-like contact can lead to sudden vaporization, igniting a plasma discharge in the corresponding confined volume, thereby destroying the tissue. After one part of the tissue is destroyed in this way, different parts of the tissue may have already contacted the advancing electrode elsewhere, leading to another vaporization, discharge, and subsequent destruction in that region. The merging of these destructions can be considered as a cut. The thermal distribution around the point-like discharge may nominally be spherical. The extent of thermal deposition may be short and may be linear. r -4 Scaling, where rThe discharge radius is the determining factor; the tissue damage zone now likely depends more on the discharge radius than on the electrode length. If the radius of a point discharge is in the range of ~10µm, a series of such discharges can cut through tissue in an “intermittent” or “discontinuous” manner by repeatedly decomposing different regions of tissue along the electrode length (i.e., at discontinuous sites, or equivalently, at non-overlapping regions), potentially leaving a damage zone only a few µm thick. By repeatedly decomposing regions of tissue, thereby modulating the electrode voltage to minimize damage from thermionic ions and the resulting thermal effects, a constant arc can be avoided, and the plasma can be kept in a glow state. Different regions of tissue within the target tissue structure that can be repeatedly decomposed can be adjacent to each other, but are not required to be.

[0047] Figure 2A An electrode assembly 4 is shown approaching tissue 2 along direction 12, with a gap 622 existing between the electrode assembly 4 and the tissue region 620 closest to the elongated electrode. In this exemplary embodiment, the two ends of the electrode assembly 4 are connected in parallel to the actuator 18 via a connector 20, and the return path to the actuator 18 is from the return electrode 24 via the connector 22. The actuator 18 can be considered as an electrical energy source that supplies electrical energy to the electrodes to generate plasma within the target tissue structure.

[0048] Figure 2B The initial momentary connection between tissue 2 and electrode assembly 4 at contact region 620 is shown, where gap 622 has been reduced to ~0.

[0049] Figure 2COne scenario is illustrated where the voltage on electrode assembly 4 is at least above the negative voltage plasma threshold in region 620 (not shown). This could cause at least one component of tissue 2 within tissue region 626 to vaporize, creating a vapor cavity 635, and potentially allowing current 624 to flow to return electrode 24, and possibly creating a damaged region 628. Such a damaged region 628 can, in turn, be limited in scope to a volume of tissue directly adjacent to tissue region 620, and either of such tissue regions 625 and 627 could be the next portion of tissue 2 that initiates vaporization in the same manner as prior to region 620, to create an intermittent process, as described elsewhere herein. Discharge can begin with vaporization of tissue surrounding the electrode and can continue if the voltage is high enough to bridge the vapor gap between the electrode and the tissue and ionize the vapor in the gap. If a portion of such an electrode is not in contact with tissue, for example, when vapor bubbles form around that region of the electrode, the electrode temperature may increase, and the resistivity may increase. For example, when connected in series to a power supply in "power-limited mode," this can happen when one part of the wire draws more current than another, as the average power may remain constant. However, localized overheating in areas of increased resistivity can cause partial vaporization and breakage of the wire. This can be mitigated (e.g., avoided) if the electrodes are placed under a common voltage, such as if both ends of the wire are connected to the same location (or "node") in the circuit. In this exemplary configuration, when one part of the electrode may become more resistive due to overheating and current may flow through the other part of the electrode, the current flowing through the heated area can be reduced, preventing wire failure, as described above regarding the series connection configuration. The speed at which the electrodes are moved can be selected to meet a constant tension condition below the wire's breaking tension. Too low a tension will reduce the speed. If the electrodes are not in contact with tissue, there may be no heat transfer from the electrodes to the tissue, and the electrode temperature may rise. The arc current can then increase due to the rise in electrode temperature, potentially triggering a positive feedback loop that, when the electrode is under relaxed and / or low-tension conditions (conditions that reduce the likelihood of small areas of tissue contacting the electrode to produce the aforementioned intermittent discharge), can in turn lead to overheating of the tissue and / or electrode. Since the plasma threshold is polarity-dependent, the discharge can act as a rectifier, and the rectified current can be used as feedback for cutting at approximately the minimum negative voltage threshold of the plasma discharge, including non-limiting example operations via glow discharge states. In this configuration, the damage zone can now depend on the discharge radius rather than the electrode length. Intermittent discharge sequences in the ~10µm range can result in damage zone thicknesses between ~1µm and ~3µm. In this configuration, the duty cycle of the power source (e.g., driver 18 or "electrical energy") can be maintained at approximately 100% due to the intermittent discharge process.

[0050] Figure 2D This illustrates a situation where the voltage on electrode assembly 4 falls below the plasma threshold and may fail to sustain vapor chamber 635, such as region 626 in the previous figure. This could cause contact region 620 to expand along electrode assembly 4, creating an extended contact region 630 that is larger than contact region 620 and allows more current 624 to flow from electrode assembly 4 through tissue 2 to return electrode 24, producing a greater current than... Figure 2C A larger damage area 628 may be formed, which can extend via thermal conduction to the portion of tissue 2 located posterior to direction 12. If the electrode voltage cannot be maintained along the vapor chamber 635 of the electrode, tissue and / or fluid may come into contact with the electrode and allow a large current to pass through the interface. The degree of damage may be proportional to the length of the electrode-tissue interface; i.e., the extended region 630. Therefore, the extent of the damage area may increase as the voltage decreases. Similarly, a large damage area may occur if voltage is not supplied to the electrode before it comes into contact with the tissue, because a relatively large portion of the electrode may come into contact with the tissue simultaneously before the discharge process begins. To avoid this damage, an overthreshold voltage may be applied to the electrode before it comes into contact with the tissue, and as per [the relevant regulations]. Figure 2C The incision is created. Another method to prevent tissue overheating may be the use of non-conductive liquids, such as Electro Lube Surgical, or viscoelastic materials (e.g., Healon). These non-conductive liquids can act as both a coolant and a preventative agent against current-related tissue damage, such as electroporation. For example, a non-conductive liquid can be injected into the cutting area to protect tissue that may be near the target tissue in the current return path. The non-conductive liquid can also be cooled before use.

[0051] Figure 2E This illustrates a scenario where the voltage on electrode assembly 4 can be greater than both the negative plasma threshold and the positive plasma threshold, and the contact region 620 has expanded along electrode assembly 4 to create a vaporization region 626, which can be greater than... Figure 2C The vaporization zone 626 in the middle. Similarly, in this configuration, compared to... Figure 2C The configuration allows more current 624 to flow from electrode assembly 4 through tissue 2 to return electrode 24, generating more current than... Figure 2C The damage zone is larger than the damage zone 628. Electrode voltages exceeding the negative plasma threshold and the positive plasma threshold may cause the electrode to become hot enough to provide self-sustaining thermionic emission. Turbulence can disrupt the vapor chamber 635 and can damage the electrode and / or tissue.

[0052] Elongated electrodes may comprise wires with a nominally circular cross-section (or “arched”), and reducing the electrode width is equivalent to reducing the diameter of the wire (or equivalently, its “cross-sectional distance”). The voltage can be kept as low as possible while still causing tissue breakdown to avoid overheating of the target tissue. The electric field from a nominally cylindrical electrode can tend to zero at a distance approximately equal to the electrode length, which, when using electrodes with an aspect ratio ≫1 (e.g., when the electrode comprises long, thin wires), can again lead to unnecessarily extended areas of damage in the tissue. The intermittent process of tissue breakdown as described herein can provide reduced areas of damage due to the inherent interruption of current flowing through the tissue that may accompany such proximity, since, in the absence of tissue destruction, current nominally flows substantially through the tissue only when the tissue is in contact with the electrode.

[0053] Although the cross-section is typically circular, the wire can be formed into square, hexagonal, flat rectangular, or other cross-sections. Therefore, electrodes can optionally be configured using conductors with nominally non-circular cross-sections (such as rectangular cross-section conductors). Such nominally non-circular cross-section wires can be obtained from Eagle alloys (Talbott, TN). Rectangular cross-section electrodes can be formed by stamping foils, such as foils also available from Eagle alloys (Talbott, TN). Non-circular cross-section electrodes can be further configured such that their thinnest dimension is nominally parallel to the translational direction to provide the electrode with deformability along the translational direction and increased stiffness in the orthogonal direction. Conductive wires or threads with high melting points that form part of the circuit can be referred to as filaments, as understood by those skilled in the art.

[0054] Figure 2F The illustration shows a case where electrode assembly 4 may include electrode regions 650, 652, and 654, which do not necessarily represent the entire incision length. As shown, the electrode has deformed during the incision, and electrode regions 652 and 654 have shifted in the direction of movement 12, while electrode region 650 has not shifted. This may occur when at least one of electrode regions 650 to 654 is flexible. As a non-limiting example, configuring electrode assembly 4 to be flexible for at least a single region of electrode regions 650 to 654, for example by using fine wires, can provide the aforementioned deformability. In an exemplary embodiment, the new tissue region closest to the electrode, the nearest-end tissue region 620, is now approached by electrode region 652, and the nearest-end tissue region 620 is... Figure 2CThe tissue region 625, and may be the next part of tissue 2 that initiates vaporization in the same manner as before region 620, to form a segmented incision. The shape of tissue 2 may be altered by the ablation of at least a single tissue region, and thus cause a portion of tissue 2 to initiate vaporization in the same manner as before region 620, to form a segmented incision.

[0055] Figure 3 Plot 610 shows the relationship between the measured polarity-dependent voltage threshold of vaporization and pulse duration for negative voltage discharge (curve 614) and positive voltage discharge (curve 612), delivered using a pulsed voltage delivered by a ~8 mm long, ~Ø50 µm tungsten filament electrode immersed in a physiologically balanced saline bath, and observed using a camera. Due to the accompanying lower current, the lower threshold voltage of the negative discharge state may contribute to producing a smaller incision than the positive discharge state. Therefore, the driver 18 can be configured to utilize a negative bias.

[0056] Pulsating voltage waveforms can be used to form the described plasma. For example, in water, a vapor chamber can be positioned at a distance of ~Ø20µm from an electrode at a speed of ~0.5m•s. -1 The electrode expands at an average velocity (averaging over a bubble lifetime of ~500 µs), operating with a nominally sinusoidal waveform and a peak voltage of ~300 V. Discharge ceases due to vapor bubble collapse (and subsequent cavitation), potentially transferring momentum between the material and the electrode. In this configuration, the time required to reignite the plasma can be on the order of milliseconds, which can be long compared to the pulse period of an excitation waveform in the ~MHz range, and requires a considerable voltage to sustain the discharge. However, if the distance between the tissue and the electrode surface decreases (e.g., by moving the electrode), decomposition may restart more quickly. The velocity of the final incision produced by the plasma may be referred to herein as the “tissue velocity.” The frequency of the pulsating electrode voltage can be configured in the ~MHz range and allows for more than one cycle during tissue decomposition and / or bubble lifetime. As a non-limiting example, the nominal type of the waveform can be selected from the group consisting of: sinusoidal waveforms, square waveforms, triangular waveforms, ramp waveforms, periodic waveforms, aperiodic waveforms, and combinations thereof. The amount of time required for the electrode to move into contact with the tissue and for vaporization can be longer than the amount of time required to complete the discharge process. When the electrode is not damaging the tissue, it may be cooling, and when the electrode is in contact with the tissue without damaging it, more energy may be needed to overcome the reduced electrode temperature as heat diffuses from the electrode into the tissue, potentially leading to tissue damage. Therefore, a lower incision duty cycle may be associated with greater thermal damage to the tissue compared to a higher incision duty cycle.

[0057] In some embodiments, failure to achieve thermal confinement can lead to collateral tissue damage. This may be the case, for example, with rigid electrodes, where the velocity is constant at all locations along the electrode, but the velocity of the tissue along the electrode may not be constant, resulting in a temporal and spatial distribution of tissue velocity along the cutting edge of the electrode. Rigid electrodes can only move at their slowest achievable cutting speed. That is, a rigid electrode may need to cut a full path along its cutting edge to advance and cut further, causing the tissue area to press against the electrode before being cut, thus limiting the instantaneous cutting speed by allowing only the average cutting speed. Hot spots along the cutting edge of a rigid electrode can provide point vaporization, but these same sites may then linger in the tissue, awaiting similar decomposition at other locations, even when using rigid elongated electrodes. The lingering time may be longer than the thermal or mechanical response time of the tissue, leading to collateral damage due to heat dissipation into the tissue, especially in the presence of excess fluid. More efficient energy utilization might involve drying the next tissue area to be cut. Actuating a rigid electrode at too fast a translational rate may not allow for a complete incision and result in “traction.” Therefore, if the actuation speed of the electrode is nominally adapted to the discharge speed within the vapor chamber 635, collateral damage can be reduced.

[0058] In some embodiments, a deformable electrode can move at segmented speeds within the material it is cutting. That is, unlike a conventional rigid electrode, a portion of a deformable electrode can advance into a cavity (or “bubble”) created by a vaporization event, and then vaporize a new area of ​​tissue before similarly advancing along other areas of the electrode, thereby allowing for a speed distribution along the instantaneous cutting speed of the electrode. Such a deformable electrode can be held under tension along its length, which in turn can cause the deformable electrode to advance through the tissue at a rate determined at least in part by the average cutting rate and at least in part by the local cutting rate, which itself can be determined at least in part by the tension on the electrode. The mass (or mass density) and / or stiffness of the deformable electrode can at least in part determine its ability to advance into the cavity created by the vaporization event. The average cutting rate may be affected by moving the electrode or electrode assembly using translational elements (or “translation devices”) and actuators (e.g., along the x-axis, where +x can be defined as the direction of the intended cut). As a non-limiting example, the translation element may be selected from the group consisting of: translation stage, linear stage, rotary stage, guide rail, rod, cylindrical sleeve, screw, roller screw, moving nut, rack, pinion, belt, chain, linear motion bearing, rotary motion bearing, cam, flexure, dovetail, and combinations thereof. As used herein, the terms "stage" and "slide" are considered equivalent when used to describe translation elements, devices, or systems. As a non-limiting example, such an actuator may be selected from the group consisting of: motor, rotary motor, squiggle motor, linear motor, solenoid, rotary solenoid, linear solenoid, voice coil, spring, moving coil, piezoelectric actuator, pneumatic actuator, hydraulic actuator, jet actuator, and combinations thereof. Optionally, the electrode assembly may be manually actuated.

[0059] In some embodiments, the tension may be selected to accommodate the stiffness of the material used to form the electrode, which may be represented, for example, by the elastic modulus. As a non-limiting example, the elastic modulus may be selected from the group consisting of: flexural modulus, Young's modulus, bulk modulus, section modulus, and shear modulus. For a deformable electrode supported by a support structure at least at a single end, the modulus of the electrode material... E It can be used to determine the allowable deflection distance. tension F Where L is the unsupported length of the electrode, and I It is the second-order moment of inertia with respect to the shape of the electrode cross-section; and for a rectangular electrode, it can be derived from... Given, among which w It is the thickness of the electrode in the direction orthogonal to the deflection direction, andh It is the thickness of the electrode in the deflection direction, for example, it can be equal to ~2. r e As mentioned earlier in this article, similarly, the second moment of a cylindrical electrode (such as a wire) can be derived from... Given, among which r This represents the radius of the cylinder.

[0060] In some embodiments, a trade-off exists between the characteristic range of the electrode (i.e., "size," "thickness," or "size") (e.g., the diameter in the case of wire or other such elongated electrodes) and its corresponding mechanical stability (and the strength and robustness of the instrument thus constructed, especially in systems involving moving elongated electrodes). Therefore, the taught stretched fine wire electrode can provide increased mechanical stability compared to a relaxed fine wire electrode. Increased mechanical stability can manifest as increased cutting accuracy (…). For example, Such an electrode is less likely to drift laterally to the cut direction. Alternative embodiments may further include a tensioning element mechanically coupled to the electrode, providing a nominally more constant tension force on the electrode. The thin, deformable, elongated electrode described herein can be considered as the fundamental mode of a simple harmonic oscillator, having a fundamental frequency (or equivalently, a mechanical resonant frequency). ,in k It is the stiffness of the material and m It is mass. The collapse of the steam cavity can cause the tensioned electrode to accelerate at least partially according to the provided tension, and the collapse of the cavity can be considered much like releasing a plucked string (i.e., the electrode). Then, the force on this tensioned, deformable, elongated electrode adjacent to the cavity having a range z F It can be understood as ,in T It is the tension on the electrode. l It is the unsupported length of the electrode, and its range. z It can be the nominal diameter of the spherical cavity, and z<<l Similarly, for a linear mass density... μ The tension electrode, ,in And for pure tungsten ρ =~9*10 3 kg•m -3 For example, consider a ~Ø10µm nominal pure tungsten wire with an unsupported length l =~10mm (i.e., ~7μg mass, or ~0.7μg·mm) -1 linear mass density μ (or equivalently, the mass per unit length)), which is in T When a tension of ~200mN is applied, the above relationship may arise. k =~40 N·m-1 , f =~12kHz, and the period is τ =~83µs. Alternatively, ~Ø 5µm nominal pure tungsten wire with an unsupported length. l =10mm, μ =~0.177μg·mm -1 ,as well as T =~100mN, can generate f =~17kHz. Optionally, ~Ø 19µm nominal pure tungsten wire with unsupported length. l =~8mm, μ =~2.55μg·mm -1 ,as well as T =~300mN, can generate f =~9.65kHz. Optionally, ~Ø12.5µm nominal pure tungsten wire with unsupported length. l =~3mm, μ =~1.1μg·mm -1 ,as well as T =~300mN, can generate f =~39.1kHz. Optionally, ~Ø200µm nominal pure tungsten wire with unsupported length. l =~12mm, μ =~282μg·mm -1 ,as well as T =~1N, can generate f =~1kHz. The force required to deform an elongated electrode can scale non-linearly with the distance of the characteristic cross-section of the electrode.

[0061] In this configuration, such electrodes can be translated in the x-direction and can be displaced (“flicked”). x =~20µm, to generate local peak velocity x’ ,in m•s -1 It can be restricted to primarily moving along the incision direction, i.e., the x-axis (i.e., parallel to the direction of electrode translation, or equivalently, transverse to the elongated direction), thereby minimizing errors transverse to the intended incision direction. Compared to configurations including rigid electrodes, such a configuration can provide reduced thermal damage and / or reduced traction because primary heat deposition and / or heat diffusion can be relatively reduced by using such deformable electrodes to better match tissue velocity. This deformable (or “flexible”) electrode can move faster than its associated plasma-cut tissue because the local velocity of the electrode can be inversely proportional to the sag on the electrode, and the electrode can tend to follow the plasma to alleviate the increased tension on it, and can move at speeds greater than ~1 m·s. -1The electrode moves at a speed that allows it to "bend," "deform," or "vibrate." Thus, an elongated electrode, as described herein, can vibrate (or equivalently "deform," or equivalently "bend") transversely to the axis of its elongation. As a non-limiting example, the table below lists various configurations and dimensions of the electrode materials and their corresponding mechanical resonant frequencies.

[0062] In some embodiments, thermal confinement can be achieved if a discharge is generated within a single cycle of the pulsating voltage waveform (e.g., within a nanosecond timeframe). From the field of laser-tissue interaction, we know that explosive vaporization by a nanosecond pulse can generate peak temperatures of ~200°C, resulting in voids (or “craters” or “cavities”) with volumes potentially ~50% larger than the substantially heated volume. Photodisruption, for example, is known to produce such damage volumes. Ejecting vapor and / or water and / or debris from the cutting region can prevent the formation of an arc discharge between the electrode and its environment, even at high temperatures; something that fine, deformable electrodes can inherently provide, especially if said deformable electrodes contact tissue along an area smaller than their circumference and generate voids larger than the interaction volume, as described regarding some effects of photodisruption nanosecond laser pulses. This expanded damage volume can facilitate the ejection of debris and / or water and / or vapor. For example, the energy E required to raise a ~Ø10µm water sphere from ~20°C to ~200°C is... However, bubbles smaller than the electrode radius can still provide a sufficiently large cavity to allow the entire electrode to pass through, for example, when tissue contact is only ~1 / 2 to ~2 / 3 of the electrode circumference (or equivalently, only ~1 / 2 to ~2 / 3 of the electrode diameter, geometrically projected onto the tissue). This is possible due to the increased volume of the resulting pit. In this case, the corresponding reduction in the energy required to induce plasma can be... Furthermore, the resulting pits may be large enough to accommodate an entire ~Ø10µm electrode, especially for mechanically compliant tissues. As a non-limiting example, for a cut width of ~10mm (or equivalently, an average linear power density of ~1.5W·mm²), -1 It can deliver ~15W of power to the electrodes at a pulse repetition frequency (“PRF”) of ~1MHz. τ 脉冲 =~1µs, providing ~15µJ of energy per cycle (or per "pulse"). For example, a ~10mm long, ~Ø10µm wire electrode according to PRF=~1MHz and E 脉冲 =~15µJ As described, the effective ablation length per pulse can be observed using the following relationship: ,and La It might be ~1.32mm. Furthermore, L a It is not necessary to include a single continuous length, but can include individual examples of discrete ablation regions or discrete ablation areas distributed along the entire electrode length, such that the individual lengths of the discontinuous regions (or equivalently, non-overlapping regions) can be summed to approximately per pulse. L a Value. The electrode can also be translated at an effective speed (or "rate"). v a Translation through organization, v a At least in part by L a Decision, such as Continuing with the previous exemplary configuration, the total effective length of ~1.32mm along the ~10mm long, ~Ø10µm electrode can reach ~660mm•s. -1 Effective translation speed v a After organizational relocation V a This is used to cut tissue, and the electrode may deform during its cutting, and the actual local peak velocity of at least a single portion of the electrode may differ from that of the electrode. v a This is due to the speed of the underlying translation via the actuator. v t And the elasticity and tension applied to the electrodes, as described elsewhere in this document. That is, v t Not necessarily equal to v a . v t It can be selected to be in ~1 mm•s -1 and ~5000mm•s -1 Between. Optionally, v t It can be selected to be in ~10mm•s -1 and ~1000 mm•s -1 Between. Optionally, v t It can be selected to be in ~50 mm•s -1 and ~500 mm•s -1 Between. As a non-limiting example, under a tension of ~300mN, according to PRF =~1MHz and E 脉冲= A 10mm long, Ø13µm tungsten wire operating at ~15µJ can achieve a speed of ~300 mm•s -1 peak v t Translation is employed to cut corneal tissue with minimal collateral damage. In light of the foregoing, a system can be configured to allow the electrode velocity to nominally match the tissue velocity, utilizing the leading edge of a plasma-induced bubble moving along the length of a deformable electrode that translates past the tissue to be cut. Variable speeds can be used, as discussed elsewhere herein.

[0063] Figure 4 The tensioned electrode assembly 5 shown may include a tensioning element 700, which is operatively coupled to the electrode 702 and attached to the electrode assembly 4 via attachments 704 and 706, such that the tensioning element 700 allows the electrode 702 to stretch (or “deform”, “bend”, or “vibrate”) upon contact with tissue 2 (not shown in this figure). The cut portion of the electrode 702 may include only a portion of the conductive portion of the electrode 702. A radius 708 located at the top of arms 710 and 712 may provide a smooth surface for the electrode 702 when stretched, avoiding excessive strain that might be applied at sharper transitions. Arms 710 and 712 can be considered as at least part of a support structure for providing mechanical stability to at least a portion of the electrode 702. A gap may exist between arms 710, 712 and may be used to receive tissue before and / or during and / or after the formation of the cut, as shown in this embodiment. In some embodiments, the electrode assembly 5 includes a support structure as described herein.

[0064] In some embodiments, a processor (e.g., a controller) is operatively coupled to an elongated electrode to provide movement to the elongated electrode. For example, the processor may be configured with instructions to control one or more components of an actuator and a moving electrode assembly. In some embodiments, the processor is configured with instructions to, for example, advance the electrode distally and pull the electrode proximally.

[0065] In some embodiments, the elongated electrode is sized for insertion into tissue, and the processor is configured to cut the tissue with the electrode to define a volume of cut tissue within a pouch. While this volume can be configured in many ways, in some embodiments, the volume includes a shape profile, such as that of a lens body. In some embodiments, the processor is configured to move the electrode by a first movement to define a first cutting surface on a first side of the tissue volume, and by a second movement to define a second cutting surface on a second side of the tissue volume. In some embodiments, the processor is configured to advance the electrode distally to define a first surface on a first side of the tissue volume, and to pull the electrode proximally to define a second surface on a second side of the tissue volume. In some embodiments, a gap extends between the elongated electrode and the support structure, and the gap is sized to receive tissue such that tissue extending into the gap is cut when the electrode is pulled proximally.

[0066] In some embodiments, the movement of the electrodes is coordinated with the shape of one or more contact plates to define a volume of tissue to be cut. In some embodiments, the contact plate includes a first configuration of a first surface on a first side defining the volume of tissue and a second configuration of a second surface on a second side defining the volume of tissue. In some embodiments, the first contact plate includes a first shape profile of the first surface on a first side defining the volume of tissue and a second shape profile of the second surface on a second side defining the volume of tissue. For example, a first surface and a second surface of a lens body including the volume of tissue. In some embodiments, the contact plate includes more than one actuator operatively coupled to a processor, and the processor is configured to instruct the contact plate to be shaped to have a first surface profile for a first incision and to be shaped to have a second profile for a second incision. In some embodiments, the processor is configured to instruct the contact plate to be shaped to have a first profile, to cut a first side with the first shape profile, to be shaped to have a second profile, and to cut a second side with the second profile, for a total time not exceeding about 10 seconds, for example not exceeding 5 seconds, or for example not exceeding 2 seconds.

[0067] The support structure may be made at least partially of materials selected from the group consisting of: tungsten, nickel-titanium, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile-butadiene-styrene, polyamide, polylactide, polyoxymethylene, polyetheretherketone, polyvinyl chloride, polylactic acid, glass, ceramics, and combinations thereof. The tensioning element 700 may be directly connected to at least a portion of the electrode assembly 4, as shown, or optionally connected to at least a portion of a subsequent element to which the electrode assembly 4 is attached; such as connector 52 or electrode assembly support 17. As a non-limiting example, the tensioning element 700 may be a spring, a coil spring, a leaf spring, a torsion spring, an elastic mesh structure, a hinge, a movable hinge, and combinations thereof. The deformable electrode may be supported by the support structure and allowed to deform while creating plasma-induced cuts within the target tissue or target tissue structure. The electrode (e.g., electrode 702 or a portion thereof) may be at least partially made of a material selected from the group consisting of: tungsten, nickel-titanium, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, and combinations thereof. Alternatively, the electrode may comprise a wire made of the same materials just listed. Alternatively, the electrode may be coated in certain areas to prevent conduction and / or cutting in said areas. Alternatively, a tube may be used instead of a coating to insulate certain areas of the electrode. Such a coating or tube may be selected from the group consisting of: polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactide, polyoxymethylene, polyetheretherketone, polyvinyl chloride, polylactic acid, glass, ceramics, and combinations thereof. The electrode (e.g., electrode 702) may be a wire with a diameter between ~3µm and ~300µm. Alternatively, the diameter of said wire may be between ~10µm and ~50µm. Alternatively, the diameter of the wire can be between ~12µm and ~17µm. The tensioning element 700 can be configured to provide tension such that the resultant force on the electrode is ~80% of the rated or measured yield strength of the electrode or its material; for example, this may be the case for a ~Ø12.5µm tungsten wire loaded with a tension of ~295mN, which may also correspond to ~0.5% elongation. Optionally, the tension can be between ~50% and ~95% of the yield strength. Optionally, the tension can be between ~70% and ~85% of the yield strength. Other configurations can be scaled using a relationship related to the second moment of inertia, as described earlier herein regarding permissible deflection distances (e.g., ~80% of the rated yield tension of ~4.7N or ~3.8N for a nominal pure tungsten wire with a diameter of ~Ø25µm). The connector 52 can be operatively coupled to the cutting electrode mechanism 502 via the connector 74.As a non-limiting example, connector 74 may be a receiver configured to receive a disposable module including element electrode 4, connector 52, and electrode support 17, wherein electrode support 17 includes matching features compatible with those of connector 74, such as threads, snap rings, snap fittings, and combinations thereof. Cutting electrode mechanism 502 may also include matching features compatible with those of connectors 71 and 72, which are mechanically coupled to actuators 50 and 504 respectively, and may provide an axis of motion to move electrode assembly 4 to create a cut in tissue 2 (not shown). Alternatively, as a non-limiting example, element electrode 4, connector 52, electrode support 17, cutting electrode mechanism 502, and connector 74 may be packaged as a disposable module into probe body 26, configured to engage with a more complete cutting system to actuate the electrode or electrode assembly or probe assembly along axis of motion 12. Although not shown for clarity, translational elements can be used to move at least some portions of the probe body 26, including the tensioning electrode assembly 5, to ensure mechanical stability and accuracy along at least one direction of motion.

[0068] Figure 5 It shows something similar to Figure 4 The tensioning electrode assembly 5, wherein radius 708 may further include channel 720, into which electrode 702 may be placed to minimize positional errors due to unintentional electrode movement, particularly positional errors transverse to the intended cut direction. Tensioning element 700 may be configured as a movable hinge (or hinge, as shown) within or along arms 710 and 712. Arms 710 and 712 may include a notched rigid material, as shown, to provide movable hinge 722. As a non-limiting example, suitable materials for manufacturing the movable hinge may be selected from the group consisting of: polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactide, polyoxymethylene, polyetheretherketone, polyvinyl chloride, copper beryllium, and combinations thereof. Where the movable hinge 722 is integrated into arms 710 or 712 and a conductive material may be selected, this cutting electrode may be brazed, soldered, adhered with a conductive adhesive, and / or welded to the arms. When the movable hinge is integrated into the arm 710 or 712 and an electrically insulating material is selected, the electrode 702 can be otherwise adhered to the arm, or brazed, soldered and / or welded to an adjacent conductive material.

[0069] Figure 6 A system for cutting tissue, system 800, is shown; the tissue is, for example, ocular tissue, including the cornea, limbus, and stroma. System 800 may include similar... Figure 4 and Figure 5The electrode assembly 4 is a tensioned electrode assembly 5. The electrode assembly 4 can be coupled to the electrode support 17 via a connector 52. As a non-limiting example, the connector 52 may be made at least partially electrically insulated. The electrode assembly 4 may include arms 710 and 712, an electrode 702, and a tensioning element 700, which is operatively coupled to the electrode 702 and attached via attachments 704 and 706 to form the tensioned electrode assembly 5, such that the tensioning element 700 allows the electrode 702 to stretch upon contact with tissue 2. Attachments 704 and / or 706 may be implemented via brazing, soldering, adhesion, compression fitting, clamping, or combinations thereof. A radius 708 located at the top of arms 710 and 712 provides a smooth surface for the electrode 702 when stretched, avoiding excessive strain that may occur at sharper corners. Tensioning element 700 can be directly connected to the conductive portion of electrode 4, or optionally connected to subsequent elements including electrode 702, such as connector 52 or electrode support 17. A notch can be formed by movement along the axis of motion 12. In the present exemplary configuration, tensioning electrode assembly 5 may include elements 700, 702, 704, 706, 708, 710, and 712; all of these may be at least partially made of at least partially conductive material and thus can be held at approximately the same voltage by a driver 18 (not shown), and all of these can be considered to include tensioning electrode assembly 5. Alternatively, electrode assembly 4 and tensioning electrode assembly 5 may be identical. Alternatively, some of the aforementioned elements may at least partially comprise electrically insulating material and therefore may not be at the same potential as other elements comprising at least partially conductive material, and electrode assembly 4 can be considered only those elements comprising at least partially conductive material and is a subsystem of tensioning electrode assembly 5, as shown. As a non-limiting example, the tensioning element 700 can be a spring, a coil spring, a leaf spring, a torsion spring, an elastic mesh structure or web, a hinge, a movable hinge, and combinations thereof. A torsion spring can be, for example, the type found in nail removers. As a non-limiting example, the electrode material, which is at least partially conductive, can be selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloys, cupronickel alloys, palladium, platinum, platinum-iridium, silver, aluminum, and combinations thereof. Alternatively, the electrode 702 can at least partially comprise wires made of the same material. Alternatively, the electrode assembly 4 can at least partially comprise elements made of an electrically insulating material. Alternatively, the electrode assembly 4 can be coated in certain areas to prevent conduction and / or cutting in said areas. Similarly, a tube can be used instead of a coating to insulate areas of the electrode assembly. As a non-limiting example, such a coating or tube may be selected from the group consisting of: polyimide, PTFE (e.g., Teflon), polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactide, polyoxymethylene, polyetheretherketone, polyvinyl chloride, polylactic acid, glass, ceramics, and combinations thereof.A return electrode (not shown) can be placed on or near the patient's eye and connected to the actuator 18. A series load between ~150Ω and ~500Ω can be positioned in line with the electrode to provide current limiting. Connector 52 can be operatively coupled to the cutting electrode mechanism 502 via connector 74. Alternatively, as a non-limiting example, element electrode 4, connector 52, electrode support 17, cutting electrode mechanism 502, connector 74, or a subset thereof can be packaged as a disposable module into probe body 26, configured to engage system 800 via connectors 71 and 72, which in turn may include matching features compatible with the features of actuators 50 and 504; such as threads, snap rings, snap fittings, and combinations thereof. Actuator 504 may provide a motion axis (or equivalently, a “translation” along the direction of motion, e.g., motion axis 14), and actuator 504 may be coupled to position encoder 51 via connection 53. Both position encoder 51 and actuator 504 may be coupled to translation device and / or actuator driver 57 via connections 55 and 59, respectively. As a non-limiting example, connections 55 and 507 may include at least one of the following: mechanical connector, electrical connector, magnetic connector, and optical connector. Actuator 504 may also provide a motion axis (e.g., motion axis 12) and may be coupled to position encoder 506 via connection 505. Both position encoder 506 and actuator 504 may be coupled to actuator driver 508 via connections 509 and 511, respectively. It should be noted that some embodiments of this disclosure may be practiced depending on only a single motion axis, such as when forming a corneal flap using a single incision. The motion axes of actuators 50 and 504, i.e., motion axes 14 and 12, can be configured to be orthogonal or at least not collinear. Actuators 504 and 50 can be configured to actuate tension electrode assembly 5 or a portion thereof along motion axes 12 and 14. Position encoders 51 and 506 can be mechanically coupled to the module mechanically connected thereto by electrode assembly 4 via connections 55 and 507, respectively, to provide more reliable position information than unconfigured sensors. Alternatively, actuator 50 can be configured to correspond to motion axis 14 (or "move along motion axis 14"), and actuator 50 can actuate (or "translate") contact plate 804, and connection 55 can be connected to contact plate 804 or a structure supporting contact plate 804. Driver 18 can be configured to provide a controlled voltage and / or controlled current to electrode 4. Driver 18 can provide an AC voltage and / or current waveform to electrode 702. As a non-limiting example, the waveform type can be selected from the group consisting of: pulsating, sinusoidal, square, sawtooth, triangular, fixed frequency, variable frequency, and combinations thereof. The driver 18 can be configured to provide a waveform with a peak-to-peak full-range voltage between ~50V and ~1000V.Alternatively, driver 18 can be configured to provide a waveform with a peak-to-peak full-range voltage between ~200V and ~500V. Driver 18 can be configured to provide a waveform with a carrier (or "fundamental") frequency between ~10kHz and ~10MHz. Alternatively, driver 18 can be configured to provide a waveform frequency between ~500kHz and ~2MHz. Alternatively, driver 18 can be configured to provide a waveform frequency between ~800kHz and ~1.2MHz. Burst duration can also be used, and the burst duration can further depend on the electrode speed. v t The driver 18 can be further modulated to include pulse trains at modulation frequencies between ~100 Hz and ~3 MHz to generate a duty cycle. The duty cycle can be between ~0.01% and ~100%. Alternatively, the duty cycle can be between ~50% and ~100%. Alternatively, the duty cycle can be between ~95% and ~100%. The driver 18 can be configured to provide an average power between ~1 W and ~25 W. Alternatively, the driver 18 can be configured to provide an average power between ~12 W and ~18 W. The driver 18 can be configured to provide energy per cycle (or equivalently, "energy per pulse") between ~1 µJ and ~100 µJ. Alternatively, the driver 18 can be configured to provide energy per cycle between ~5 µJ and ~50 µJ. Alternatively, the driver 18 can be configured to provide energy per cycle between ~10 µJ and ~20 µJ.

[0070] In some embodiments, a flap can be described as an incision that creates a "flap" of tissue that can be lifted and pivoted based on a "hinge" to provide access to the tissue beneath. As a non-limiting example, cutting a segment of tissue to a depth of 130 µm and flattening a plane below that depth below the tissue surface may create a flap with an uncut edge acting as a hinge. The flap can be truncated by completing the uncut edge of the exemplary incision. In some embodiments, a pouch can be described as an incision that separates a first depth (or layer) of tissue from a second depth (or layer) of tissue segment without necessarily forming a flap. As a further non-limiting example, cutting one side of tissue to a certain depth and flattening a plane below that depth below the tissue surface may create a pouch.

[0071] In some embodiments, a significant drop in the input impedance of the driver 18 due to plasma discharge at electrode 702 may cause local current spikes, which could in turn damage the electrode and / or cause tissue damage. The power delivered to the electrode (or equivalently, "delivered power" or equivalently, "maximum power output") can be limited to avoid this. The average power suitable for practicing embodiments of this disclosure can be ~1 W·mm-1 and ~10W•mm -1 During this period, especially during glow discharge, the power delivered may be higher during initial exposure to better ensure the initiation of dielectric breakdown. Alternatively, the voltage and / or current waveforms (or alternatively, power control signals) used to power the electrode 702 may be further modulated or adjusted to allow for instantaneous or desired length and / or electrode translation speed at which it engages with tissue. v t Proportional.

[0072] As a non-limiting example, when cutting the cornea, the voltage can be increased from an initial value corresponding to when electrode 702 is about to initially engage tissue or is expected to initially engage tissue and nominally points towards a more central corneal region, to a higher voltage corresponding to when electrode 702 is passing through or is expected to pass through the central cornea and thus has a relatively larger tissue engagement length than initially; then, the electrode voltage can be reduced as electrode 702 continues to pass through cornea 2 and cut tissue with an inherently smaller engagement length, the reduction being configured to be the opposite of the initial increase, but not necessarily so. As described elsewhere herein, the position of electrode 702 within cornea 2 can be inferred using an encoder in the translation subsystem. In one embodiment, the voltage provided by the driver 18 can be configured to provide a maximum peak-to-peak bipolar nominal sinusoidal voltage of ~500V (including both ~+250V and ~-250V amplitudes, which are not necessarily ground voltages relative to the nominal neutral point voltage), with a PRF (or "carrier frequency") of ~1MHz, which can rise from ~0V to the maximum amplitude during the initial ~50µs of translation, and then return to ~0V during the last ~100µs of translation. This may be useful, for example, when the tensioned electrode assembly 5 includes a ~10mm long, ~Ø10µm, ~99.99% pure tungsten wire cut for the electrode 702, which is tensioned to ~300mN by the tensioning element 700 and along direction 12 at ~300mm•s. -1 Maximum speed (i.e.) v t,max Translation, with a constant acceleration of 2,000 mm·s⁻¹ -2 The initial electrode position is between ~4 mm and ~7 mm from the nearest point to the target tissue to be cut. It should be noted that such constant acceleration can produce a linear velocity distribution, in which the electrode may remain within the target tissue, for example, to form a flap or lenticule, rather than a complete incision, as will be described elsewhere in this document.

[0073] In some embodiments, monitor 514 may be configured to monitor the voltage and / or current supplied to electrode assembly 4 via connection 516 and to provide data about the voltage and / or current to driver 18 via connection 518. The data about the voltage and / or current of electrode assembly 4 may be in the form of a signal from a comparator. System controller 60 may be operatively coupled to driver 18 via connection 62, which is at least unidirectional. Alternatively, connection 62 may also be bidirectional, wherein controller 60 is capable of sensing and / or responding to signals at least from driver 18. Signals from monitor 514 may also be provided to system controller 60 and thereby act on system controller 60 to control the cuts created by electrode assembly 4. Monitor 514 may reside within system controller 60 and / or communicate with system controller 60 via driver 18. Such signals may be safety signals associated with the sensed voltage or current, such as when the voltage or current is outside a specified limit. In another alternative embodiment, driver 18 and / or monitor 514 may provide feedback to controller 60 or inherently use such feedback. As a non-limiting example, this feedback can be EMF or current feedback and can be used to determine when the electrode assembly 4 contacts the tissue and / or plasma. For example, this condition could be whether the plasma is in a glow discharge state. Connection 65 connects the controller 60 to the actuator 50, and is at least a unidirectional connection. The actuator 50 may include at least one electric motor and may further include a position encoder. Connection 65 may optionally be a bidirectional connection, where signals such as position, velocity, acceleration, out-of-range error, etc., are shared between the controller 60 and the actuator 50. In another alternative embodiment, the actuator 50 may provide feedback to the controller 60 or inherently use such feedback, and may share this feedback as a signal with the controller 60. As a non-limiting example, this feedback can be force feedback and can be used to determine when the electrode assembly 4 contacts the tissue or when excessive force is applied to the tissue to be cut. Similarly, connection 67 connects the controller 60 to the power supply 70, and is at least a unidirectional connection. In another alternative embodiment, the power supply 70 may provide feedback to the controller 60 or inherently use such feedback, and may share such feedback as a signal with the controller 60. As a non-limiting example, such feedback may be an error signal. Such an error signal may be a temperature error, input voltage error, output voltage error, input current error, output current error, etc. Similarly, the connector 68 connects the controller 60 to the user interface 80, and is at least a unidirectional connection from the user interface 80 to the controller 60. In another alternative embodiment, the user interface 80 may provide feedback to the controller 60 or inherently use such feedback, and may share such feedback as a signal with the controller 60.For example, the user interface 80 may be a graphical user interface, button, or foot pedal for signaling the actuator 50 to move the electrode assembly 4 and cut tissue. Actuator drivers 57 and 508 may be connected to the system controller 60 via connectors 65 and 510, respectively. The user interface 80 may be connected to the system controller 60 via connector 68 and transmit user commands through the system controller 60.

[0074] In some embodiments, system controller 60 includes a processor configured with instructions to determine the contours of tissue to be removed from the eye to provide refractive correction. The processor may be configured to determine the shape contours of one or more plates used to provide refractive correction to a patient. Similarly, although reference is made to controller 60, controller 60 may include components of a distributed computing system and may be operatively connected to one or more processors, such as a distributed processing system, as described herein.

[0075] In some embodiments, system 800 may further include a contact plate 804, a support element 802, a suction element 810, and an accompanying vacuum device for securing the contact tissue 2. An incision 42 can be formed in tissue 2 (in this exemplary embodiment, the cornea and / or corneal stroma) by using actuator 504 to move at least some portions of the tensioned electrode assembly 5 along the axis of motion 12 to create a bed 43. The contact plate 804 can be incorporated to flatten the cornea by moving it along the axis of motion 14 using actuator 50. The contact plate 804 may further include a contact surface 806 (not shown). The contact plate 804 can be used to flatten the cornea, particularly when the contact surface 806 is nominally approximately planar. As a non-limiting example, the contact plate 804 may be configured as a planar glass window to allow visibility through it. As a non-limiting example, the contact plate 804 may be made of a material selected from the group consisting of glass, crystal, ceramic, metal, polymer, and combinations thereof. A contact element 808 (not shown) may be placed on the distal surface of the contact plate 804 to provide a clean and / or sterile surface for contact with tissue 2, and may be configured as a thin, conformal, peel-and-apply sterile barrier, which may also be disposable. As a non-limiting example, the contact element 808 may be made of a material selected from the group consisting of polyethylene (PE), polyvinyl chloride (PVC), polypropylene (PP), oriented PP (OPP), biaxially oriented PP (BOPP), polyethylene terephthalate (PET), and combinations thereof. The contact plate 804 may be at least partially supported by a support member 802. The support member 802 may also at least partially support elements of the tensioned electrode assembly 5, such as arms 710 and 712, and thereby also support the electrode 702 and the tensioning element 700 to form at least a portion of the electrode assembly 4 and the tensioned electrode assembly 5. Thus, arms 710 and 712 can be considered as support structures for the electrode 702. Optionally, the support 802 can be operatively coupled to the probe body 26 and / or the sheath 6. Optionally, the contact plate 804 can be moved relative to the tissue 2 together with the support 802. A suction element 810 can be used to stabilize the tissue 2 containing the eye relative to the contact plate 804 and / or the electrode 4. The suction element 810 can be configured as a nominally open annular ring as shown, or fixation to the eye can be achieved by any other applicable structure, such as a single open pouch or more than one open pouch. The suction element 810 can be operatively coupled to a vacuum pump 850 via a vacuum line 870 to provide negative pressure within the suction element 810. For patient safety and system reliability, a vacuum switch 852 and / or a vacuum sensor 854 can be placed between the suction element 810 and the vacuum pump 850 and connected via connections 860 and 862, respectively. The system controller 60 can be connected to the vacuum pump 850, the vacuum switch 852, and the vacuum sensor 854 via electrical connections 864, 866, and 868, respectively.In the current configuration, actuator 50 can be configured to correspond to the motion axis 14, and actuator 50 can actuate (or "translate") contact plate 804, and connection portion 55 can be connected to contact plate 804 or such structure supporting contact plate 804. Contact plate 804 can move at ~0.1 mm·s. -1 and ~1000 mm·s -1 The rate or velocity translation between them, and in an alternative embodiment, it can be ~10 mm·s. -1 and ~100mm·s -1 The rate translation between them. The motion corresponding to actuator 50 can be configured to be at least partially synchronized with the motion corresponding to actuator 504 or its velocity distribution.

[0076] In some embodiments, system 800 may be further configured such that the tensioned electrode assembly 5 at least partially includes electrode 702. Electrode 702 may include a tungsten wire with a diameter of ~12.5µm and a purity of at least ~99%, which traverses arms 710 and 712 to form a bridge pitch of ~12mm, and uses a mechanical helical spring to apply a tension of, for example, ~300mN to electrode 702.

[0077] In some embodiments, the incision can be a flap or a pouch, or a combination thereof, based on whether the electrode cutting width is approximately greater than or equal to the lateral extent of the target tissue structure to be cut and whether the electrode penetrates laterally outward from the tissue. That is, a flap can be formed in the anterior position of the cornea by flattening or otherwise compressing the anterior corneal surface using a contact plate 804 to produce a lateral dimension of incision 42 between ~3 mm and ~11 mm, or optionally between ~8 mm and ~10 mm, all of which can be smaller than the aforementioned bridge distance providing the flap incision. As shown, the flap incision can be configured to provide a D-shaped incision 42, wherein the straight segment of the D-shaped incision can be a hinge portion. Similarly, a pouch incision can be formed if the electrode bridge distance is smaller than the lateral extent of the compressed cornea presented to the electrode. Alternatively, a pouch incision can be configured to allow the electrode to penetrate the entire distance of the cornea to form a combined flap / pouch incision, and an incision with a fully rounded rectangle or partially rounded rectangle shape can be produced (e.g., when configured to include a straight, uncut portion). In an alternative embodiment, driver 18 may be configured to provide a sinusoidal waveform having a peak-to-peak full-range voltage of ~250V and a power limit of ~15W at a frequency of ~1MHz, so as to achieve a speed of ~200mm·s⁻¹. -1 and ~0mm·s -1 (i.e., when the electrode stops at the incision end) v t =~0 mm·s -1The electrode translation rate between them is along the direction of motion 12 and the corneal tissue is cut using steps 102 to 122 of flowcharts 100 and 200, as follows. Figure 7 and Figure 9 As shown. Step 202 of flowchart 200 can be used to interrupt power supply to the electrode in coordination with the movement of the electrode and contact plate 804, such that a nominal voltage of ~0V is supplied to the electrode during the transition period between the electrode moving in a first direction and then in a second direction, for example, if the contact plate 804 moves in the direction of movement 14 to remove a portion of tissue (e.g., a “lens” of tissue within the matrix). Alternatively, the electrode voltage and / or power can be a function of the electrode speed, and / or position, and / or cutting range, as described elsewhere herein.

[0078] Alternatively, variable acceleration can be used to form the motion profile of the electrode, thereby producing a nonlinear velocity profile. Such a motion profile may require a higher-order control model and incorporate "jerk" and / or "snap" and / or "crackle" and / or "pop" factors to provide asymmetric acceleration / deceleration, such that, as a non-limiting example, in the initial ~50µs... v t The range and the final ~10µs v t The ranges are similar.

[0079] When controlling (e.g., "modulating") the power of the electrodes, velocity and / or velocity distribution and / or effective slit width can be taken into account.

[0080] As a non-limiting example, the power of electrode 702 can be adjusted by selecting the maximum value of a group of parameters selected from voltage, current, carrier frequency, modulation frequency, duty cycle, power setpoint, power limit, per-pulse energy setpoint, per-pulse energy limit, and combinations thereof.

[0081] As a non-limiting example, a modulation relationship describing the controlled power output of the electrode 702 driven by driver 18 may be selected from the following: a fixed relationship, a constant relationship, a linear relationship, a nonlinear relationship, a logarithmic relationship, a sinusoidal relationship, an exponential relationship, a polynomial relationship, and combinations thereof. The relationship may be positive or negative, depending on the current system configuration, and may be determined using the descriptions and equations included herein. The controlled power output may be considered as instantaneous power and / or average power and / or peak power. As a non-limiting example, the modulation may be implemented via control of driver 18. The term modulation is used herein to indicate a change in an otherwise consistent output, waveform, or signal. As used herein, a “modulated” waveform is equivalent to an “envelope” waveform, and a “modulated envelope” is equivalent to an “envelope”. Alternatively, modulation may not be used to envelop the waveform, including inherently pulsating waveforms.

[0082] As a non-limiting example, when forming a corneal flap incision, the duty cycle... D c The effective cut width can be represented by... y a Modulate the effective cut width using the composite relationship. y a It can be simulated as having a radius of R The chord length of the circle is the distance into the target tissue. x c (That is, the height of the round hat) multiplied by the velocity distribution v t The function to obtain You can use R and v t,max The nominal value is normalized to provide a general envelope function.

[0083] Alternatively, the voltage required for vaporization U Can be regarded as And the electrode voltage is provided to the electrode 702 by the driver 18. V At least one component of the modulation relationship can be It should be noted that the preceding examples involve at least part of the exponential relationship, since the root is the inverse function of the power.

[0084] Alternatively, the energy supplied per cycle to electrode 702 by driver 18 can be configured to deliver energy that is at least partially dependent on... v t The value and / or at least in part depends on the effective cut width. y a The value of energy per cycle.

[0085] Alternatively, the duty cycle supplied to electrode 702 by driver 18 can be configured to deliver at least partially dependent on v t The value and / or at least in part depends on the effective cut width. y a The duty cycle of the value.

[0086] Alternatively, the voltage supplied to electrode 702 by driver 18 can be configured to deliver a voltage that is at least partially dependent on... v t The value and / or at least in part depends on the effective cut width. y a The voltage value.

[0087] Alternatively, the current limit provided to electrode 702 by driver 18 can be configured such that the delivery is at least partially dependent on... v t The value and / or at least in part depends on the effective cut width. y a The current limit of the value.

[0088] Alternatively, the power limit or setpoint provided by the driver 18 to the electrode 702 can be configured to deliver power that is at least partially dependent on the power supply. v t The value and / or at least in part depends on the effective cut width. y a The value of the power limit or setpoint.

[0089] Alternatively, the PRF supplied to electrode 702 by driver 18 can be configured to deliver at least partially dependent on v t The value and / or at least in part depends on the effective cut width. y a The value of PRF.

[0090] Optionally, v t It can depend at least in part on the effective cut width. y a and / or x c ,in As described elsewhere in this article.

[0091] Alternatively, this may be useful, for example, when the tensioned electrode assembly 5 comprises a ~10 mm long, ~Ø20 µm, ~99.99% pure tungsten wire for the cut portion of electrode 702, which is tensioned by tensioning element 700 to ~300 mN and at a rate of ~200 mm·s. -1The maximum speed is translational along direction 12, with a constant acceleration of ~1,000 mm·s. -2 The initial electrode position is located between ~2 mm and ~4 mm from the nearest orientation to the target tissue to be cut (i.e., the point closest to the electrode along the axis of motion of the electrode). The voltage provided by the driver 18 can be configured to deliver a maximum peak-to-peak bipolar nominal sinusoidal voltage of ~600V (relative to the nominal neutral voltage, including both ~+300V and ~-300V amplitudes), with a PRF (or “carrier frequency”) of ~1MHz, which linearly rises from ~0V to the maximum amplitude during the initial ~50µs of translation and returns to ~0V during the last ~50µs of translation.

[0092] In another alternative embodiment, the duty cycle provided by driver 18 can be configured to deliver a maximum amplitude that rises from ~0% to between ~70% and ~100% during the initial ~50µs of translation, and returns to a duty cycle of ~0% during the final ~10µs of translation. This duty cycle can be created using a modulation frequency such as a square wave gating function. The square wave gating function can be configured to have variable "on" and / or "off" times. The relationship between the variable "on" and / or "off" times can be described elsewhere herein with respect to relationships used to describe the controlled power output of the electrodes.

[0093] In another alternative embodiment, the duty cycle provided by driver 18 can be configured to deliver a duty cycle that may depend at least in part on v t The value, and the speed of the electrode from rest (i.e. v t = 0mm·s -1 When the duty cycle is increased to its maximum value, it can rise from 0% to a maximum amplitude between ~70% and ~100%, and then decrease to ~0% when the electrode speed drops back to rest.

[0094] In another alternative embodiment, the maximum power output provided by the driver 18 can be configured to deliver such a maximum power output, which may at least partially depend on v t The maximum output power can rise from ~0% to a maximum amplitude between ~70% and ~100% as the electrode speed increases from rest to its maximum value, and then decreases to 0% when the electrode speed returns to rest.

[0095] In another alternative embodiment, the voltage provided by the driver 18 can be configured to deliver a voltage that may at least partially depend on v tThe voltage can rise from ~0% to a maximum amplitude between ~70% and ~100% as the electrode velocity increases from rest to its maximum value, and then drop to 0% when the electrode velocity returns to rest.

[0096] Figure 7 A method for cutting tissue is described. Flowchart 100 includes steps 102-122, which can be performed sequentially or in any suitable order. In step 102, the eye to be treated is selected. Step 104 involves activating the system, and step 106 involves positioning a probe onto the tissue to be treated. Step 108 involves activating a vacuum system to fix the tissue relative to the probe (e.g., via the vacuum system described above). Step 110 involves positioning a contact plate onto the tissue in a first position. Step 112 involves supplying power to the electrodes. Step 114 includes translating (or "moving" or "actuating") the electrodes in a first direction (e.g., along the axis of motion 12, "+x direction"). Step 116 includes interrupting the supply of power to the electrodes. Step 118 involves disengaging the vacuum fixation device and releasing the tissue, thus separating the eye being treated. Step 120 involves separating the electrodes from the just-cut tissue. Step 122 involves deactivating the system and separating it from the eye. When the system is separated from the patient, the thin electrodes may break. Alternatively, the electrode can be translated in a second direction, nominally opposite to the first direction. Alternatively, steps 108 and 110 can be interchanged, and power can be supplied to the electrode once it contacts tissue 2. Alternatively, steps 116 to 120 can be omitted to produce a resection. Alternatively, steps 116 and 118 can be omitted if there is only a low risk of collateral damage due to tissue heating when the actuator changes direction. Alternatively, step 116 can involve a gradual reduction of power to the electrode, and step 112 can involve a gradual increase of power to the electrode, as described elsewhere herein.

[0097] although Figure 7 Methods for cutting tissue according to some embodiments are illustrated, but those skilled in the art will recognize that many adjustments and variations can be made according to the present invention. For example, the steps can be performed in any suitable order, some steps can be repeated, some steps can be omitted, and combinations thereof.

[0098] In some embodiments, the processor as described herein is configured to execute Figure 7 Instructions for one or more steps of a method.

[0099] Figures 8A to 8D Regarding the details of the embodiments according to the present invention, wherein the tensioned electrode assembly 5 is now in conjunction with Figures 4 to 6The orthogonal view shows that the motion axis 12 can now enter and leave the plane of the view, while the motion axis 14 can be vertical, and wherein, it can follow Figure 7 The steps. Figure 8A The contact plate 804 is shown to be configured to be located within the middle portion of the support 802 and movable relative to the support 802 along the axis of motion 14. The contact surface 806 of the contact plate 804 may be generally planar and generally parallel to the cutting portion of the electrode 702. In this view, the electrode 702 is shown initially behind the cornea. A contact element 808 may be placed on the contact surface 806 to produce a sterile, disposable item used only during a single process. The contact element 808 may nominally conform to at least a portion of the contact surface 806. The portion of the contact surface 806 conforming to the contact element 808 may be the central portion. A suction element 810 may be configured to contact tissue 2 containing the eye in an area near the outer cornea and / or the limbus 838, as shown, to fix and stabilize the cornea 843 (not shown in this figure). Alternatively, the suction element 810 may be made to contact at least one orientation of the cornea 843 to better stabilize the tissue 2 relative to the cutting of the electrode 702. The cornea 843 may include an anterior corneal surface and a posterior corneal surface. In this case, the target tissue 2 can be considered as the stromal tissue within the cornea 843 and contained between the anterior and posterior corneal surfaces. An intraocular lens 840 is shown for orientation purposes and may be a natural or artificial lens. In this embodiment, the contact element contacts the apex of the anterior corneal surface of the cornea 843. As shown, the electrode assembly 4 may include arms 710 and 712, and an electrode 702. The current configuration of the figure can represent... Figure 7 Steps 102, 104, and 106.

[0100] Figure 8B It shows Figure 8A The system, in which the contact plate 804 and therefore the contact element 808 may have been moved further along the axis of motion 14 to flatten the cornea 843 and the tissue 2 therein. The electrode 702 can be made to cut the tissue 2 along the axis of motion 12 through a path, as described elsewhere herein, to create an incision 45 and thereby create a bed 43 (not shown in this view). The current configuration of the figure can represent Figure 7 Steps 108, 110, 112, and 114.

[0101] Figure 8C It shows different orientations Figure 8BThe system, as demonstrated by motion axes 12 and 14, allows the incision 45 to be seen advancing through tissue 2 as the electrode 702 translates along motion axis 12 (shown in this view as proceeding from left to right). Actuation of electrode 702 can be in its final position, as may be the case, for example, when forming a flap incision.

[0102] Figure 8D It shows Figures 8A-8C The system in which the contact plate 804 and therefore the contact element 808 are movable along the axis of motion 14 to stop precisely at the apex of the corneal surface, such as Figure 8A As shown. The current figure now shows an incision 45, which forms the surface of a bed 43 (not shown). The surface shape of the resulting bed 43 can be nominally characterized as the surface shape with respect to the anterior corneal surface. Alternatively, the surface shape of the central region of the resulting bed 43 (not shown) can be characterized as the average of at least some portions of the surface shapes of the anterior corneal surface and the contact surface 806 (or contact element 808). The average can nominally be an arithmetic mean, a geometric mean, a harmonic mean, a weighted mean, or a combination thereof. The configuration of the current figure can represent Figure 7 Steps 116, 118, 120, and 122.

[0103] Figure 9 Described similar to Figure 7 The method has additional steps 202 to 212; wherein step 116 may be optional, and electrode cutting is permitted during step 202. That is, steps 116 and 118 may be omitted if there is only a low risk of collateral damage due to tissue heating when the actuator changes direction, and / or strain on the unpowered electrode may cause failure of the electrode due to the change in the position of the contact plate. Step 202 involves positioning the contact plate in a second position, which may be a translation of the entire element or a translation of at least a portion of the element. Translation of at least a portion of the element may be used to create a non-planar contact plate surface to provide the desired corneal deformation, as per the description of the contact plate. Figure 11A and Figure 11BAlternatively, at step 202, the contact plates can be interchanged to provide the desired corneal deformation. This corneal deformation may be designed to form a surface defining at least a portion of the lenticule, such as bed 43, to achieve at least a portion of the desired three-dimensional tissue resection contour. The lenticule can then be removed to induce a refractive change in the cornea 843 of the patient's eye. If step 202 is removed, step 204 may be optional, but in other respects may be similar to step 112. Step 206 involves translating the electrode in a second direction. This second direction may nominally be opposite to the first direction. Step 208 involves separating the electrode from the tissue, for example, if the translation in step 206 brings the electrode outside the tissue 2. Step 210 involves disconnecting the power supply to the electrode and may be similar to... Figure 7 Step 116. Step 212 involves separating the vacuum fixation device and releasing the tissue and separating the eye being treated, and can be similar to... Figure 7 Step 118. Step 122 involves... Figure 7 Step 122 similarly deactivates the system and separates it from the eye.

[0104] although Figure 9 Methods for cutting tissue according to some embodiments are illustrated, but those skilled in the art will recognize that many adjustments and variations can be made according to this disclosure. For example, the steps can be performed in any suitable order, some steps can be repeated, some steps can be omitted, and combinations thereof.

[0105] In some embodiments, the processor as described herein is configured to execute Figure 9 Instructions for one or more steps of a method.

[0106] Figures 10A to 10F For similar Figures 8A to 8D The system is further configured such that the shape of the contact surface 806 can be configured to be non-planar and shown as convex. Furthermore, a lens body (e.g., lens body 820) can be cut within the (stromal) tissue 2 of the cornea 843. The difference between the first and second cutting contours can correspond to the shape of the lens body of the tissue to be removed from the cornea to treat refractive errors of the eye.

[0107] Figure 10A It shows the relationship with Figure 8A A similarly configured system adds a curved surface 806 to the contact plate 804. Similarly, the contact element 806 is placed on the curved contact surface 806 and nominally matches the curvature. The current configuration can be represented... Figure 7 and Figure 9 Steps 102 to 108.

[0108] Figure 10B It shows Figure 10A The system in which the contact plate 804, and therefore the contact element 808, may have moved further along the axis of motion 14 to contact the cornea 843 and the tissue 2 therein. Figures 8A to 8C The configuration differs; in the current diagram configuration, the cornea is not necessarily flattened, but rather subjected to varying degrees of compression to at least partially match the curvature (or "shape," where the curvature alone is insufficient to adequately describe the contact surface 806) of the contact surface 806 to create the incision 46. The current diagram configuration can represent... Figure 7 and Figure 9 Steps 110 to 112.

[0109] Figure 10C It shows the previous different orientations Figures 10A to 10B The system, as shown by motion axes 12 and 14, makes it appear as if the incision 45 is advancing through the tissue 2 as the electrode 702 translates along motion axis 12 (shown in this view as proceeding from left to right). Actuation of the electrode 702 can be in its final position, as may be the case, for example, when forming a flap incision.

[0110] Figure 10D The previous one was shown Figures 10A to 10C The system, in which the contact plate 804 has been translated forward, now shows a cut 46. Such a cut 46 can form the surface of a bed 44 (not shown). The resulting surface shape of the bed 44 can be characterized as the average of the surface shapes of the anterior corneal surface and the contact surface 806 (or contact element 808). This average can nominally be an arithmetic mean, a geometric mean, a harmonic mean, a weighted average, or a combination thereof.

[0111] Figure 10E The previous one was shown Figures 10A to 10D The system, in which a second incision, 45, can now be formed. The current configuration of the diagram can represent... Figure 9 Steps 202-206. Alternatively, the cut 45 can be formed by interchangeing the contact plate 804 or portions thereof to provide different surface shapes for the cut 45. A flat contact surface may be used for at least one cut.

[0112] Figure 10F It shows the use of the front Figures 10A to 10E The system processes the eye in which the lens body 820 has been cut within the (stromal) tissue 2 of the cornea 843 and the surface defined by incisions 45, 46. Incisions 45, 46 may include incision 47 when the electrodes are used to cut across the entire cornea rather than forming a pocket within the cornea. The current configuration of the figure represents completion. Figure 9The results of the remaining steps. The shape of the surface formed by the incisions 45, 46 can be selected to affect the refractive correction of the cornea 843 of the patient's eye. The refractive correction can be defined at least in part by diagnostic measurements such as corneal aberration measurement, ocular aberration measurement, wavefront aberration measurement, corneal topography, and combinations thereof, wherein the nominal shape of the lens body can be defined by the aberrations measured by optical balance (or correction), as described in Sekundo W. Small Incision Lenticule Extraction (SMILE) Principles, Techniques, Complication Management, and Future Concepts. 2015. Springer Cham Heidelberg; and related citations therein.

[0113] In some embodiments, for the cornea, the approximate tissue contour of the tissue to be removed can be represented as:

[0114] T(x, y) ~=W(x, y) / (n-1), where T is the thickness (in micrometers), W is the wavefront error (in micrometers), n is the refractive index of the cornea, and x and y are coordinate references corresponding to a plane (such as the plane near the pupil or the apex of the cornea). The wavefront error can be expressed in many ways, such as in height in micrometers, or, for example, using a single Zernike coefficient.

[0115] Other methods can be used to determine the thickness distribution of the tissue to be removed, such as referring to the SMILE procedure known to those skilled in the art.

[0116] Figure 11A and Figure 11B A segmented, adjustable contact plate 804 is used to deform the cornea to form a lenticule or other treatment incision. The adjustable contact plate 804 is operatively coupled to a controller and configured, for example, with reference to the small-incision lenticule extraction described herein, to shape the cornea to provide refractive correction. Figure 11A A segmented adjustable contact plate 804 is depicted, including a sub-plate (or equivalently, "element") 8061, which together can form a contact surface 806, and the sub-plate 8061 can be accommodated in a housing 8042 and mounted to a base 8044. Figure 11B The same contact plate 804 is depicted in cross-sectional view to expose the actuator 8100 operably coupled to the sub-plate 8061 within the housing 8042. In this embodiment, each sub-plate 8061 can be attached to the actuator 8100 to allow each sub-plate 8061 to be individually actuated using an additional actuator and associated monitoring and control subsystems, as per [reference to...]. Figure 6The system shown and described (the connections are not shown in the current figures) is as follows. As a non-limiting example, the sub-board 8061 may be adhered to the actuator 8100 using epoxy resin or brazed. The actuator 8100 may be selected from the group consisting of piezoelectric actuators, motors, pneumatic actuators, jet actuators, and combinations thereof. As shown in the exemplary embodiment, the sub-element 8062 may be constructed using a material selected from the group consisting of glass, ceramics, quartz, silicon, metals, polymers, and combinations thereof. Such a sub-board 8061 may be actuated along a motion axis (e.g., motion axis 14). These subplates 8061 can be translated (or “displaced”) to form segmented contact surfaces 806 with free-form profiles (or “shapes” or “surface profiles”), to form contact surfaces 806 with discrete but arbitrarily addressable profiles for forming cuts 45 and / or cuts 46 to resolve optical aberrations, including higher-order aberrations such as defocus, radial distortion, spherical aberrations, cylindrical aberrations, astigmatism, coma, and trefoil, when defining the pattern of a lens body removed from tissue 2 within cornea 843. As shown, such subplates 8061 can be configured nominally rectangular, but not necessarily rectangular, and other geometries are considered within the scope of this disclosure. Contact elements 808 (not shown) can be placed on the distal surface of contact plates 804 to provide a clean and / or sterile surface for contact with tissue 2 and can be configured as a thin, conformal, peel-and-apply sterile barrier, which can also be disposable, as described elsewhere herein. Not utilizing Figure 9 Step 202 is used to reposition the contact plate 804. However, the current embodiment allows modification of step 202 to reconfigure the contact plate to a second configuration before forming another cut. The number of actuators 8100 can be determined by the spatial resolution requirements and / or tolerances of the surface pattern for a given scheme. As a non-limiting example, there can be an array of 10 actuators 8100 with a square cross-sectional shape, or an array of 14 such actuators 8100, or an array of 28 such actuators 8100; when configured in a square package within a disk-shaped contact surface with a nominal diameter of 12 mm, it produces ~2.0 mm per actuator 8100. 2 ~1.44mm 2 and ~0.80mm 2 The area. Alternatively, a more regular array, such as a 4×4 square array, can be used to generate 16 actuators 8100. When the regular array of the 16 actuators 8100 with square cross-sections is concentrically positioned with a disk-shaped contact surface with a nominal diameter of 12 mm, the area for each actuator can be ~9 mm². 2 Although the corners of the array may lie outside the 12mm disk boundary. Similarly, a 10×10 square array can produce ~1.44mm for each actuator.2 The area.

[0117] Alternatively, the customized contact plate 804 and / or contact surface 806 may be manufactured to include surface profiles for forming incisions 45 and / or 46 to resolve higher-order aberrations when defining the pattern of a lens body removed from tissue 2 within the cornea 843. Alternatively, such customized contact plate 804 and / or contact surface 806 may be used alone to form incisions 45 and / or 46. Alternatively, a first customized contact plate 804 and / or contact surface 806 may be used to form incision 45, and a second customized contact plate 804 and / or contact surface 806 may be used to form incision 46, wherein the first and second customized contact plates 804 and / or contact surfaces 806 may be configured to have different surface profiles. (Not utilizing...) Figure 9 Instead of step 202 to reposition the contact plate 804, the current embodiment allows modification of step 202 to replace (or “interchange”) the second contact plate before forming another cut. Methods for manufacturing such a custom contact plate 804 and / or contact surface 806 can be freely selected from the group consisting of additional manufacturing, injection molding, machining, and combinations thereof.

[0118] In some embodiments, an optical scheme may include one or more of the following: surface curvature, optical power in refractive power, material properties, refractive index, wavefront measurement of the eye, or thickness. In some embodiments, the surface pattern of an optical element may be defined as a perturbation of the optical surface from the optical scheme. Low-frequency errors are typically specified as irregularities, off-fringe, or flatness, and tend to divert light from the center of the airy disk pattern into the first few diffraction rings. This effect can reduce the size of the point spread function without widening it, thus reducing the Strehl ratio. Mid-frequency errors (or small-angle scattering) can be specified using a slope or (PSD) requirement and tend to widen or smear the point spread function (PSF) and reduce contrast. Both low-frequency and mid-frequency errors degrade the performance of an optical system. However, some pattern defects can be omitted from the surface pattern specification; optical power and occasional astigmatism may be examples of this. Optical systems may allow individual optics to be focused, off-center, or tilted to compensate for specific aberrations. Surface accuracy and surface pattern are terms frequently used to describe these two areas. To disambiguate, micrometers may be used as the unit of measurement in the specification.

[0119] Figure 12A and Figure 12B It is for the formation of a disc-shaped lens. Figure 12A A lens body 820 is shown, which includes a front surface 451 and a rear surface 461, the front surface 451 being able to... Figure 7 and Figure 9 Step 114 is created by cut 45, and the rear surface 461 can be accessed through... Figure 9 Step 206 is created by cut 46. Hinge 1020 can be accessed via... Figure 9 Step 202 (i.e., the contact plate is translated to the second position between forming cuts 46 and 45) is used to form the lens. In this figure, when the lens body is unfolded on a flat surface, the lens body looks like a flat disk, as shown. Figure 12B It shows Figure 12A A cross-sectional view of the same lens body 820. In the present embodiment, the nominally planar contact plate can be positioned at a first location (or "depth" or "site") to form cutout 46, and then translated to a second, more forward (or "proximal") location to form cutout 45. In the configuration of the present embodiment, the cross-sectional shape 1010 can be nominally rectangular, and the faces 451 and 461 can be nominally parallel. Alternatively, by appropriately translating the contact plate, cutout 45 can be formed at a location further back (or "far") than cutout 46.

[0120] According to embodiments of this disclosure, Figure 13 For similar Figure 12B A plano-convex lens body. Here, the lens body 820 includes a front surface 451 that can be formed by a notch 45 and a rear surface 461 that can be formed by a notch 46. A contact plate or an element including a contact plate with more than one translational element can be configured to produce a non-planar type surface for the surface 451. As shown, the configuration of the present embodiment can be used to form a plano-convex lens body.

[0121] According to embodiments of this disclosure, Figure 14 For similar Figure 13 A meniscus lens body. Here, the lens body 820 includes a front surface 451 that can be formed by a notch 45 and a rear surface 461 that can be formed by a notch 46. A contact plate, or an element including a contact plate with more than one translational element, can be configured to produce non-planar surfaces for the two surfaces 451 and 461. As shown, the configuration of the present embodiment can be used to form a meniscus lens body.

[0122] Figure 15 Similar to embodiments according to this disclosure Figure 14 A hybrid lens body. Here, the lens body 820 includes a front surface 451 that can be formed by a notch 45 and a rear surface 461 that can be formed by a notch 46. A contact plate, or an element including a contact plate with more than one translational element, can be configured to produce non-planar surfaces for the two surfaces 451 and 461. As shown, the configuration of the present embodiment can be used to form a meniscus lens body.

[0123] Figure 16A and Figure 16B Histological images of incisions in a pig cornea created according to embodiments of the present disclosure. Figure 16A Image 900 is shown, a conventional sagittal section (H&E staining) histological micrograph of a porcine cornea, cut while fresh (≤2 days post-harvest, stored at ~2°C) and subsequently fixed in 4% paraformaldehyde solution. The cutting system configuration was as follows: PRF ~1MHz, V ~±250V, sinusoidal waveform, P rms ~15W; v t,max ~400mm·s -1 Constant acceleration ~2000 mm•s -2 The electrode assembly consists of a ~Ø15µm, L~10mm, ~99.99% pure tungsten wire electrode; T~290mN; a displacement of ~35µm after the contact plate (flat) between incisions 45 and 46, and a vacuum gauge pressure of ~-500mmHg measured at vacuum sensor 854 for the suction element 810. The electrode assembly translation is accomplished using an M-664.164 piezoelectric motor actuator from PI in Karlsruhe, Germany. The target tissue 2 is corneal stroma tissue. Incision 45 is dissected to expose surfaces 451 and 452. Incision 46 remains intact, and the lens body 820 is in place. Damage may be visible as darker streaks along incisions 45 and 46, and may be within a range of approximately ~3µm. Figure 16B Image 902 is shown, which is related to Figure 16A The images are similar, but at a higher magnification, and the spacing between incisions 45 and 46 differs due to translation via a ~50µm rear contact plate. Similarly, the narrow damage area is evident.

[0124] Figure 17 For graph 910, an exemplary electrode voltage versus time waveform 912 including features according to embodiments of the present disclosure is displayed. Waveform 912 includes various cycles 914. Pulse train 916 includes pulses (cycles 914) and is constrained by a modulation envelope 918. The modulation envelope 918 can be configured as a combination of relationships described elsewhere herein, including pulsation, duty cycle, and modulation (e.g., ramp) relationships. Although shown here at the level of pulses and pulse trains for clarity, the entire cutout waveform can be configured similarly.

[0125] Figure 18 For image 960, which is a 576-pixel × 464-pixel frame, it would be comparable to using a high-speed digital camera such as the AOS M-VIT 4000 (AOS Technologies, Daettwil, Switzerland) configured with an equivalent ISO of 6400 and a shutter speed (or "integration time") of ~250µs. sh Obtained during operation. In this figure, more than one vapor chamber 635 along image element 962 can show an intermittent destruction process, which can correspond to an electrode translation of about one diameter, for similar... Figures 6 to 10E The configured cutting system, v t *t sh →~13µm and PRF* t sh →~250 cycles of a 1MHz waveform: v t,max ~400mm·s -1 Constant acceleration ~2000 mm•s -2 ; ~Ø13µm, L~10mm, ~≥99.99% pure tungsten wire electrode; T~280mN; the vacuum gauge pressure of the suction element 810 is ~-640mmHg, which is measured using vacuum sensor 854, and nominally used Figure 17 The waveform. When electrode 702 (located at image element 962, but obscured in this figure) is actuated to translate along axis of motion 12 in direction 121 to form an incision within cornea 843, more than one vapor cavity 635 may be visible along image element 962. More than one vapor cavity 635 may include a region that emits light in association with plasma formation, and the light may include a wavelength that is a function of plasma temperature and may be in the range of approximately 400 nm to approximately 750 nm.

[0126] According to embodiments of this disclosure, the technology dependence of scleral incisions can be reduced by using a plasma-induced cutting tool to semi-automatically form flaps, which limits tissue damage and provides predictable, accurate, and precise incisions in the sclera and / or cornea (including the sclera-limbus). According to embodiments of this disclosure, a pouch can be formed in the sclera and / or cornea, including the sclera-limbus, instead of a conventionally used flap. Further embodiments may provide cutting of other tissues, such as… Figure 1A The tissues listed herein. As non-limiting examples, plasma-induced incisions can be formed in the capsule to produce capsulorhexis; plasma-induced incisions can be formed in the lens to produce lens fragments or simplify lens fragment and / or lens removal; plasma-induced incisions can be formed in the retina to produce a bag or flap; plasma-induced incisions can be formed in the TM to improve drainage and / or reduce intraocular pressure; and plasma-induced incisions can be formed in the iris to perform iridotomy.

[0127] A flap can be described as an incision that creates a "flask" of tissue, which can be lifted and pivoted based on a "hinge" to provide access to the tissue beneath. As a non-limiting example, cutting three sides of a square to 50% depth and flattening the plane 50% below the edge of the square in tissue can create a half-thickness flap, where the fourth uncut side of the square acts as its hinge. The flap can be truncated by completing the fourth side of the exemplary square incision.

[0128] A pouch can be described as an incision that separates tissue of a first depth (or layer) from tissue of a second depth (or layer) without necessarily forming a flap. As another non-limiting example, cutting one side of a square to 50% depth and flattening the plane 50% depth below the edge of the square of tissue can produce a pouch of half thickness.

[0129] Semi-automatic cutting tools can be used to produce improved cuts than those produced by conventional sharp-edged instruments. Plasma-induced semi-automatic cutting tools can be used to produce improved cuts than those configured for use with conventional sharp-edged instruments.

[0130] A semi-automatic cutting system with at least one degree of motion can be used to form 5×5 mm and 4×4 mm lobes instead of manually forming them. For example, a system including 5 mm wide and 4 mm wide "blades" can be used to form 5×5 mm and 4×4 mm lobes, respectively. The electrode may include wire and / or blades.

[0131] Figure 19A Lobe 40 is shown in tissue 2 as seen above. Figure 19B The same lobe 40 is shown as seen in cross-section AA. Lobe 40 is formed by cuts 42 and 44, which form a bed 43 and form the three sides of a square (in Figures 19A-19D In the example, although other such shapes are considered within the scope of this disclosure. The lobe can be lifted and hinged around the missing side of the square to expose the underlying tissue. Bed 43 can be planar or curved. The lobe can be truncated by completing the fourth side of the exemplary square cut.

[0132] Similar to Figure 19A and Figure 19B The structure, Figure 19C The image shows bag 41 in tissue 2 as seen above, and... Figure 19D The same bag 41 as seen in cross-section AA is shown. However, in this configuration, bag 41 includes a cut 42 that forms a bed 43, but lacks a cut 44. Similarly, bed 43 can be planar or curved, but in this case it will depend on the longitudinal shape (or "profile") of the incisor to avoid forming a cut 44.

[0133] Figure 20 For a system according to an embodiment of the present disclosure, the system is configured to form a rectangular flap or pouch, which can be used in tubuloplasty for reducing intraocular pressure in glaucoma treatment. Tissue 2 can be cut using electrode 4, which in this exemplary embodiment is configured in a U-shape with width 6 and length 8, and includes a bend 10. Electrode 4 can be connected to a power RF driver 18 via lead 20. Lead 22 can be connected to a patient-generating electrode 24, which can in turn be part of a return path. The RF driver can generate bipolar pulses. Electrode 4 can be enclosed within a sheath 16, which, for clarity, is shown here partially cut off. A direction of motion 12 can be used to provide the lateral extent of the incision, and a direction of motion 14 can be orthogonal to the direction of motion 12 and perpendicular to the plane formed by the width 6 of the U-shape of electrode 4, for example, which can be used to form a tissue flap and / or pouch. Alternatively, direction of motion 14 can be used to create an incision nominally perpendicular to the surface of tissue 2. Width 6 can be selected between 1 mm and 10 mm, particularly 4 mm or 5 mm, as described above. The length 8 can be greater than the width 6, but the distance it passes through the tissue is less than the length 8. For example, a 4mm × 4mm flap can be formed by configuring the width 6 to be 4mm and the length 8 to be greater than 4mm, but with the length 8 passing through the tissue by 4mm along the direction of movement 12.

[0134] Figure 21 Similar to what is seen from the side Figure 20 The system is configured to form a flap; a probe body 26 is added to include an electrode 4, a sheath 16, and an actuator 50; and it is oriented at an angle 30 relative to the surface of tissue 2. The actuator 50 is operatively coupled to the electrode 4 and movable in directions of motion 12 and 14, such that the electrode 4 translates within tissue 2 along a motion profile formed by: first in direction 32; then in direction 34; then in direction 36 (opposite to direction 34); and then in direction 38 (opposite to direction 32). This configuration can then form a flap 40 by forming an incision 42, then an incision 44, and a bed 43 (not explicitly shown for clarity). By way of non-limiting example, the actuator 50 can be powered, such as by a motor or voice coil. Alternatively, the actuator 50 may include a series of springs and ratchet or stoppers and triggers to produce the formed motion profile. Component electrode 4 and / or sheath 6 and / or probe body 26 can be configured as a subsystem that engages with actuator 50 and RF driver 18 and is discarded after use. In another embodiment, the truncated lobe can be truncated by changing the motion profile as follows: first moving in direction 32; then moving in direction 34; and then moving in direction 38, which is opposite to direction 32.

[0135] Optionally, Figure 21The system can be configured such that the actuator 50 first translates the electrode 4 in a direction nominally along angle 30, and then retracts the electrode 4 in a second direction nominally opposite to the first direction, so as to form a pouch instead of a lobe.

[0136] Alternatively, the second electrode can also be used to form a second lobe or bag of a different size and / or shape than the first lobe or bag. For example, a 5mm × 5mm lobe can be manufactured first, followed by a 4mm × 4mm lobe. An exemplary 4mm × 4mm lobe can also be a truncated lobe.

[0137] Figures 22A-22C Details regarding the configuration of an electrode according to embodiments of the present disclosure, wherein electrode 4 includes regions 300, 302 and a bend 10. Nominally, the surface area can remain constant along electrode 4. As a non-limiting example, electrode 4 may comprise a solid wire with a diameter between ~50µm and ~300µm and is made of a material selected from the group consisting of tungsten, nitinol, steel, copper, stainless steel, beryllium copper alloy, cupronickel alloy, and aluminum. Furthermore, in alternative embodiments, the electrode may be at least partially coated with another conductive material, such as gold. Region 302 may comprise the same basic structure as region 300, modified by being compressed in a direction parallel to the image plane and elongated in an orthogonal direction. Such a configuration can maintain the surface area while providing increased strength in the aforementioned orthogonal direction by reducing dimension 303 to be smaller than dimension 301, thereby improving reliability and strength when cutting tissue. The bend 10 may be formed by the configuration of region 300, the configuration of region 302, or as a transition between regions 300 and 302. Alternatively, regions 300 and 302 and / or the bend 10 can be connected by different materials. In another alternative embodiment, the electrode 4 can be made of a tungsten wire with a diameter of ~250µm, which is compressed everywhere except in region 300, which is ~3mm long. The dimension 301 of region 300 is nominally the same as the ~250µm natural diameter of the tungsten wire. The natural bend 10 is located near region 300 with a radius of ~0.5mm to produce a width 6 of ~4mm, and the dimension 303 is configured to be formed by the aforementioned compression and is compressed to ~400µm.

[0138] For clarity, electrode 4 has been shown as U-shaped so far, but it need not be U-shaped. The Rf driver 18 can supply alternating current to electrode 4. As a non-limiting example, this alternating current can be: a sine wave, a square wave, a sawtooth wave, a triangle wave, or a combination thereof. The signal provided by the Rf driver 18 can be configured to have a base (or “carrier”) frequency between ~10 kHz and ~10 MHz, and can be further modulated to include pulse trains at frequencies between ~100 Hz and ~3 MHz to generate a duty cycle. The duty cycle can be between ~0.01% and 100%. In an alternative embodiment, the duty cycle can be between ~60% and ~80%. The peak-to-peak voltage provided by the rf driver 18 can be between ~500 V and ~2000 V. In an alternative embodiment, the peak-to-peak voltage provided by the rf driver 18 can be between ~400 V and ~800 V. In one embodiment, the signal of the RF driver 18 can be configured to have a peak-to-peak bipolar voltage of ~800V (including amplitudes of ~+400V and ~-400V), a carrier frequency of ~1MHz, and a modulation frequency of ~10kHz, which may be useful, for example, when the electrode 4 in region 300 comprises a tungsten filament with a diameter of ~Ø100µm.

[0139] Figure 23For a system 400 configured according to an embodiment of the present disclosure, in addition to the elements relating to the preceding figures, system 400 includes a controller 60, a power supply 70, a user interface 80, and a connector 52. Connector 62 connects the controller 60 to an RF driver 18, and is at least a unidirectional connection. Connector 62 may also be a bidirectional connection, wherein the controller 60 is capable of sensing and / or responding to signals at least from the RF driver 18. Such signals may be safety signals related to sensed voltage or current. In another alternative embodiment, the RF driver 18 may provide feedback to the controller 60 or inherently use such feedback, and may share such feedback as a signal with the controller 60. Such feedback may be, for example, EMF or current feedback, and may be used to determine when the electrode 4 contacts tissue and / or plasma. For example, this condition may be whether the plasma is in a glow discharge state. Similarly, connector 65 connects the controller 60 to an actuator 50, and is at least a unidirectional connection. Actuator 50 may include at least one electric motor and may also include a position encoder. Connection 65 can optionally be a bidirectional connection, where signals are shared between controller 60 and actuator 50, such as position, velocity, acceleration, and out-of-range errors. In another alternative embodiment, actuator 50 can provide feedback to controller 60 or inherently use such feedback, and can share this feedback as a signal with controller 60. This feedback can be, for example, force feedback, and can be used to determine when electrode 4 contacts tissue or when excessive force is applied to the tissue to be cut. Similarly, connection 67 connects controller 60 to power supply 70, and is at least a unidirectional connection. In another alternative embodiment, power supply 70 can provide feedback to controller 60 or inherently use such feedback, and can share this feedback as a signal with controller 60. Such feedback can be, for example, an error signal. Such error signals can be temperature errors, input voltage errors, output voltage errors, input current errors, output current errors, etc. Similarly, connection 68 connects controller 60 to user interface 80, and is at least a unidirectional connection. In another alternative embodiment, interface 80 may provide feedback to controller 60 or inherently use such feedback, and may share such feedback as a signal with controller 60. For example, user interface 80 may be a graphical user interface or button for signaling actuator 50 to move electrode 4 and cut tissue. This exemplary embodiment of system 400 also includes a connector 52 for coupling electrode 4 to actuator 50, such that electrode 4 is movable, as described with respect to the previous figures. Connector 52 may be made of an electrically insulating material and configured to electrically isolate electrode 4 from at least one other element of system 400. Connector 52 and / or sheath 16 and electrode 4 may be coupled to a subsystem that may be discarded after use.Although not shown, an alternative embodiment is a configuration for the connector 52 that allows the connector 52 to connect both sides of the (exemplary) U-shaped electrode 4 to the actuator 50. The electrode 4 may be connected by the actuator 50 at a speed of ~200 mm·s. -1 The rate of translation.

[0140] The symbol “~” is used in this text to mean “about”. For example, a statement such as “~100ms” is equivalent to a statement “about 100ms”, and similar statements… v t =~5mm•s -1 The statement “” is equivalent to “ v t Approximately 5 mm•s -1 ".

[0141] The symbol “Ø” is used in this document to indicate that the following values ​​are diameters. For example, a statement such as “Ø10µm” is equivalent to a statement that “the diameter is 10µm”. Furthermore, a statement such as “~Ø12µm” is equivalent to a statement that “the diameter is approximately 12µm”.

[0142] The symbol “∝” is used in this article to represent proportions. For example, symbols such as “∝” r -2 The statement “” is equivalent to “ r -2 The phrase "proportional" is used.

[0143] For clarity and brevity, this article uses dot notation to represent compound units. For example, the statement k =~40N•m -1 Equivalent to the statement " k =~40N per meter.

[0144] The term "mN" used in this article refers to "millinewyntons," which is 10⁻⁶ N. -3 Newton.

[0145] As described herein, the computing devices and systems described and / or illustrated herein broadly refer to any type or form of computing device or system capable of executing computer-readable instructions, such as those included in the modules described herein. In their most basic configuration, these computing devices may each include at least one memory device and at least one physical processor.

[0146] As used herein, the term "memory" or "memory device" generally refers to any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical disk drive, cache, variations or combinations thereof, or any other suitable memory for storage.

[0147] Furthermore, as used herein, the term "processor" or "physical processor" generally refers to a processing unit of any type or form of hardware implementation capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the aforementioned memory devices. Examples of physical processors include, but are not limited to, microprocessors, microcontrollers, central processing units (CPUs), field-programmable gate arrays (FPGAs) implementing soft-core processors, application-specific integrated circuits (ASICs), portions of one or more of these, variations or combinations thereof, or any other suitable physical processor. The processor may include distributed processor systems, such as those running parallel processors or remote processors (e.g., servers), and combinations thereof.

[0148] Although shown as separate elements, the method steps described and / or illustrated herein may represent parts of a single application. Furthermore, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, enable the computing device to perform one or more tasks, such as the method steps.

[0149] Furthermore, one or more devices described herein can convert data, physical devices, and / or representations of physical devices from one form to another. Additionally or optionally, one or more modules described herein can convert a processor, volatile memory, non-volatile memory, and / or any other part of the physical computing device from one form of computing device to another by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0150] As used herein, the term "computer-readable medium" generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transport media such as carrier waves and non-transient media such as magnetic storage media (e.g., hard disk drives, magnetic tape drives, and floppy disks), optical storage media (e.g., optical discs (CDs), digital video disks (DVDs), and Blu-ray disks), electronic storage media (e.g., solid-state drives and flash memory media) and other distribution systems.

[0151] Those skilled in the art will recognize that any process or method disclosed herein can be modified in various ways. The process parameters and order of the steps described and / or illustrated herein are given by way of example only and can be changed as needed. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order shown or discussed.

[0152] The various exemplary methods described and / or illustrated herein may omit one or more steps described or illustrated herein, or include additional steps in addition to those disclosed. Furthermore, steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0153] The processor described herein can be configured to perform one or more steps of any of the methods disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods disclosed herein.

[0154] Unless otherwise stated, the terms “connected to” and “linked to” (and their derivatives) used in the specification and claims shall be interpreted as allowing direct and indirect (i.e., via other elements or components) connections.

[0155] Unless otherwise stated, the terms “operably connected to” and “operably coupled to” (and their derivatives) used in the specification and claims shall be interpreted as allowing direct and indirect (i.e., via other elements or components) connections to perform functions.

[0156] Furthermore, the terms “a” or “an” as used in the specification and claims shall be interpreted as meaning “at least one”. Finally, for ease of use, the terms “comprising” and “having” (and their derivatives) as used in the specification and claims may be used interchangeably with the word “comprising” and shall have the same meaning as the word “comprising”.

[0157] The processor disclosed herein may be configured with instructions to perform any one or more steps of any of the methods disclosed herein.

[0158] It will be understood that although the terms “first,” “second,” “third,” etc., may be used herein to describe various layers, elements, components, regions, or sections, they do not imply any particular order or sequence of events. These terms are used only to distinguish one layer, element, component, region, or section from another. The first layer, element, component, region, or section described herein may be referred to as the second layer, element, component, region, or section without departing from the teachings of this disclosure.

[0159] As used in this article, the term "or" is used inclusively to refer to both alternatives and combinations.

[0160] As used in this article, characters such as numbers refer to similar elements.

[0161] This disclosure includes the following numbered clauses.

[0162] Clause 1. A system for cutting tissue with plasma, comprising:

[0163] An elongated electrode configured to flex and generate the plasma to cut tissue; an electrical energy source operatively coupled to the elongated electrode and configured to supply electrical energy to the electrode to generate the plasma; and a tensioning element operatively coupled to the elongated electrode and configured to provide tension to the elongated electrode to allow the elongated electrode to flex in response to the elongated electrode engaging tissue and generating the plasma.

[0164] Clause 2. The system according to Clause 1 further includes more than one arm operatively coupled to the electrode and the tensioning element.

[0165] Clause 3. The system according to Clause 2, wherein the electrode is unsupported between the two arms.

[0166] Clause 4. The system according to Clause 2, wherein the electrode is configured to vibrate transversely to an axis of extension of the electrode.

[0167] Clause 5. The system according to Clause 2 further includes a support structure operatively coupled to the more than one arm and the tensioning element, wherein the support structure is configured to advance the more than one arm and the tensioning element to advance the elongated electrode into the tissue to cut the tissue.

[0168] Clause 6. The system according to Clause 5, wherein the cut portion of the elongated electrode is suspended between the more than one arm under tension from the tensioning element, and wherein the gap extends between the more than one arm.

[0169] Clause 7. The system according to Clause 6, wherein the gap extends between the cut portion of the elongated electrode, the more than one arm, and the support structure.

[0170] Clause 8. The system according to Clause 6, wherein the size of the gap is set to receive cut tissue along the incision formed by the elongated electrode.

[0171] Clause 9. The system according to Clause 5, wherein the support structure is operatively coupled to one or more actuators to move the elongated electrode in one or more directions.

[0172] Clause 10. The system according to Clause 9, wherein one or more actuators are configured to move the electrode at a variable speed.

[0173] Clause 11. The system according to Clause 1, wherein the tensioning element is selected from the group consisting of springs, coil springs, leaf springs, torsion springs, mesh structures, hinges, and movable hinges.

[0174] Clause 12. The system according to Clause 1, wherein the elongated electrode comprises a first portion of an elongated filament, and wherein the tensioning element comprises a second portion of the elongated filament, the second portion being shaped to tension the elongated electrode.

[0175] Clause 13. The system according to Clause 1 further includes an electrode assembly including a support structure operatively coupled to more than one arm and the tensioning element, wherein the electrode assembly is configured to advance the electrode into tissue to cut the tissue.

[0176] Clause 14. The system according to Clause 1, wherein the electrodes are configured to sequentially contact more than one site of tissue to create an incision.

[0177] Clause 15. The system according to Clause 14, wherein the more than one part includes more than one discontinuous part.

[0178] Clause 16. The system according to Clause 15, wherein the electrode is configured to vaporize tissue in contact with the electrode at each of the more than one discontinuous site.

[0179] Clause 17. The system according to Clause 1, wherein the electrode is configured to generate more than one flash of light at more than one site when the electrode cuts tissue.

[0180] Clause 18. The system according to Clause 17, wherein the more than one light energy flash includes visible light energy, the visible light energy including wavelengths in the range of about 400 nm to about 750 nm.

[0181] Clause 19. The system as described in Clause 17, wherein each of the more than one light flash includes a maximum span of no more than about 1 mm.

[0182] Clause 20. The system according to Clause 17, wherein the more than one flash is generated within a time interval not exceeding about 250 µs and optionally not exceeding about 25 µs.

[0183] Clause 21. The system according to Clause 17, wherein the more than one flash is generated with an electrode movement distance not exceeding about 100 µm and optionally not exceeding about 10 µm.

[0184] Clause 22. The system according to Clause 17, wherein the more than one flash is distributed in more than one non-overlapping region.

[0185] Clause 23. The system according to Clause 22, wherein the more than one non-overlapping region is positioned along the elongated electrode.

[0186] Clause 24. The system according to Clause 17, wherein the more than one flash is generated at a first rate at a first speed of the electrode and at a second rate at a second speed of the electrode, wherein the first rate is greater than the second rate when the first speed is less than the second speed, and wherein the first rate is less than the second rate when the first speed is greater than the second speed.

[0187] Clause 25. The system according to Clause 24, wherein the more than one flash is generated at a substantially constant rate of about 25%, and wherein one or more of the pulse rate or pulse train rate of the waveform applied to the elongated electrode is changed in response to the rate of change of the electrode to maintain the substantially constant rate.

[0188] Clause 26. The system according to Clause 1, wherein the elongated electrode comprises a filament, and wherein the filament comprises one or more wires or strands.

[0189] Clause 27. The system according to Clause 1, wherein the elongated electrode comprises a wire.

[0190] Clause 28. The system according to Clause 27, wherein the diameter of said wire is in the range of 5µm to 200µm, optionally in the range of about 5µm to about 100µm, optionally in the range of about 5µm to about 50µm, optionally in the range of about 5µm to about 25µm, or optionally in the range of about 5µm to about 20µm.

[0191] Clause 29. The system according to Clause 1, wherein the elongated electrode includes a cross-sectional distance, and wherein the cross-sectional distance includes no more than about 25 µm.

[0192] Clause 30. The system according to Clause 1, wherein the elongated electrode operatively coupled to the tensioning element comprises a mechanical resonant frequency in the range of about 1 kHz to about 100 kHz and optionally in the range of about 2 kHz to about 50 kHz.

[0193] Clause 31. The system according to Clause 1, wherein the tensioning element is configured to tension the elongated electrode with a force in the range of about 20 mN to about 2 N and optionally in the range of about 50 mN to about 1 N and further optionally in the range of about 100 mN to about 500 mN.

[0194] Clause 32. The system according to Clause 1, wherein the elongated electrode comprises approximately 0.2 µg·mm -1 Approximately 3µg•mm -1 The mass per unit length within the range.

[0195] Clause 33. The system according to Clause 1, wherein the elongated electrode comprises a material selected from the group consisting of tungsten, nickelinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver and aluminum.

[0196] Clause 34. The system of Clause 1, wherein the elongated electrode includes an axis along the elongation direction of the electrode, and wherein the electrode is configured to move in a direction transverse to the axis to cut tissue.

[0197] Clause 35. The system according to Clause 1, wherein the elongated electrode is configured to extend in a direction transverse to the elongation direction of the electrode at a speed greater than about 1 m·s. -1 It cuts tissue at a speed that allows it to do so.

[0198] Clause 36. The system according to Clause 1, wherein the elongated electrode is configured to extend at approximately 0.5 cm·s in a direction transverse to the elongation direction of the electrode. -1 Approximately 10 cm•s -1 Within the range and optionally about 1 cm•s -1 Approximately 5 cm•s-1 It can cut tissue at speeds within a certain range.

[0199] Clause 37. The system according to Clause 1, wherein the electrodes are configured at approximately 5 mm 2 •s -1 Approximately 50,000 mm 2 •s -1 Within the range and optionally about 500 mm 2 •s -1 Approximately 25,000 mm 2 •s -1 The area of ​​tissue cut at a rate within the specified range.

[0200] Clause 38. The system according to Clause 1, wherein the electrical energy is configured to deliver a waveform, wherein the waveform includes one or more of a pulsating waveform, a sine waveform, a square waveform, a sawtooth waveform, a triangular waveform, a fixed-frequency waveform, a variable-frequency waveform, or a gated waveform.

[0201] Clause 39. The system according to Clause 38, wherein the waveform includes the sine waveform, and wherein the sine waveform includes frequencies in the range of about 0.5 MHz to about 2 MHz.

[0202] Clause 40. The system according to Clause 38, wherein the waveform comprises a combination of the sine waveform and the gating waveform, wherein the sine waveform comprises a frequency in the range of about 0.5 MHz to about 2 MHz, and wherein the gating waveform comprises a gating frequency in the range of about 20 kHz to about 80 kHz and a duty cycle in the range of about 35% to about 100%.

[0203] Clause 41. The system according to Clause 1 further includes a controller operatively coupled to the electrical energy source.

[0204] Clause 42. The system according to Clause 41, wherein the controller is configured to control the parameters of the electrical energy source by modulating the waveform using parameters selected from the group consisting of voltage, current, carrier frequency, modulation frequency, duty cycle, power setpoint, power limit, per-pulse energy setpoint, per-pulse energy limit, and modulation envelope.

[0205] Clause 43. The system according to Clause 42, wherein the waveform includes a pulsating voltage waveform comprising pulses and a substantially constant frequency in the range of about 10 kHz to about 10 MHz and optionally in the range of about 0.5 MHz to about 2 MHz.

[0206] Clause 44. The system according to Clause 43, wherein the waveform provides per-pulse energy in the range of about 0.5 µJ to about 50 µJ and optionally in the range of about 1 µJ to about 10 µJ.

[0207] Clause 45. The system according to Clause 44, wherein the controller is configured to modulate the waveform of the substantially constant frequency to generate a pulse train.

[0208] Clause 46. The system according to Clause 45, wherein the frequency of said pulse train is in the range of about 100 Hz to about 3 MHz, and optionally in the range of about 1 kHz to about 100 kHz.

[0209] Clause 47. The system according to Clause 46, wherein the waveform from the electrical energy source is configured to provide an average power in the range of about 1W to about 25W.

[0210] Clause 48. The system according to Clause 5 further includes a translation element operatively coupled to the support structure and configured to guide the support structure along a motion axis transverse to the extension axis of the electrode.

[0211] Clause 49. The system according to Clause 48, wherein the translation element is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a guide rail, a rod, a cylindrical sleeve, a lead screw, a roller lead screw, a moving nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a wedge tenon.

[0212] Clause 50. The system according to Clause 49 includes an actuator operatively coupled to the translational element to move the support structure along a motion axis.

[0213] Clause 51. The system according to Clause 50, wherein the translation element is manually actuated.

[0214] Clause 52. The system according to Clause 50, wherein the actuator is selected from the group consisting of a motor, a rotary motor, a kinetic motor, a linear motor, a solenoid, a rotary solenoid, a linear solenoid, a voice coil, a spring, a moving coil, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, and a jet actuator.

[0215] Clause 53. The system according to Clause 5, wherein a portion of the support structure comprises a material selected from the group consisting of tungsten, nickelitan, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactide, polyoxymethylene, polyetheretherketone, polyvinyl chloride, polylactic acid, glass, and ceramics.

[0216] Clause 54. The system according to Clause 48, wherein the translation element comprises a first translation element having a first axis of motion and a second translation element having a second axis of motion different from the first axis of motion.

[0217] Clause 55. The system according to Clause 54, wherein the first translation element and the second translation element are respectively selected from the group consisting of a free translation stage, a linear stage, a rotary stage, a guide rail, a rod, a cylindrical sleeve, a lead screw, a roller lead screw, a moving nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a wedge tenon.

[0218] Clause 56. The system according to Clause 55 further includes a contact plate operatively coupled to the second translational element to engage a portion of the tissue prior to cutting the tissue with the electrode, thereby shaping the tissue.

[0219] Clause 57. The system according to Clause 1 further includes a contact plate operatively coupled to the elongated electrode, the contact plate being configured to engage a portion of the cornea prior to cutting the cornea with the electrode to shaped the cornea.

[0220] Clause 58. The system according to Clause 57, wherein the contact plate includes a first contact plate having a first surface profile and a second contact plate having a second surface profile, the difference between the first surface profile and the second surface profile corresponding to refractive correction of the eye to correct refractive errors of the eye.

[0221] Clause 59. The system according to Clause 57, wherein the contact plate includes a free-form optical surface shaped to correct wavefront aberrations of the eye.

[0222] Clause 60. The system according to Clause 57, wherein the contact plate includes more than one independently adjustable actuator for corneal shaping.

[0223] Clause 61. The system according to Clause 60, wherein the contact plate comprises more than one plate operatively coupled to the independently adjustable actuator for corneal shaping.

[0224] Clause 62. The system according to Clause 61, wherein each of the more than one plate is configured to be driven to a first position and a second position at each of the more than one site, the difference between the first position and the second position corresponding to the shape profile of tissue to be removed from the cornea to improve refractive errors of the eye.

[0225] Clause 63. The system according to Clause 62, wherein the more than one site includes more than one two-dimensional site, and the shape profile includes a three-dimensional tissue resection profile.

[0226] Clause 64. The system according to Clause 60, wherein the more than one actuator comprises at least 10 actuators, and optionally, wherein the more than one actuator comprises at least 16 actuators, and optionally, wherein the more than one actuator comprises at least 42 actuators, and optionally, wherein the more than one actuator comprises at least 100 actuators.

[0227] Clause 65. The system according to Clause 60, wherein the contact plate includes a deformable membrane operatively coupled to the more than one independently adjustable actuator.

[0228] Clause 66. The system according to Clause 60, wherein the contact plate includes a first configuration for forming a first incision with the electrode along a first cutting profile and a second configuration for forming a second incision with the electrode along a second cutting profile, and wherein the difference between the first cutting profile and the second cutting profile corresponds to the shape of a lens body of tissue to be removed from the cornea to treat refractive errors of the eye.

[0229] Clause 67. The system according to Clause 57, wherein the contact plate is configured to correct one or more of the spherical, cylindrical, coma, spherical aberration, or trefoil aberration of the eye.

[0230] Clause 68. The system according to Clause 57 further includes a suction element for engaging tissue when the first translation element moves the electrode to cut the tissue, and holding the tissue in contact with the second translation element in a substantially fixed position.

[0231] Clause 69. The system described in Clause 57 further includes a sterile barrier for placement on the contact plate to keep the eye sterile.

[0232] Clause 70. The system according to Clause 69, wherein the sterile barrier comprises a thin conformal barrier to conform to the shape of the contact plate, the sterile barrier being located between the eye and the contact plate.

[0233] Clause 71. The system according to Clause 69, wherein the sterile barrier includes a peel-and-stick sterile barrier.

[0234] Clause 72. The system pursuant to Clause 57, wherein:

[0235] The length of the elongated electrode is in the range of about 6 mm to about 12 mm; the tissue includes corneal tissue; the electrode includes a wire with a diameter in the range of about 5 µm to about 20 µm; and wherein the tensioning element is configured to provide the electrode with a tension in the range of about 100 mN to about 500 mN.

[0236] Clause 73. The system according to Clause 1 further includes: a processor operatively coupled to the elongated electrode, the processor being configured with instructions for advancing the electrode distally and pulling the electrode proximally.

[0237] Clause 74. The system according to Clause 73, wherein: the elongated electrode is sized for insertion into tissue; the processor is configured with instructions to cut tissue with the electrode to define the volume of the cut tissue; and wherein the volume includes a shape profile.

[0238] Clause 75. The system according to Clause 74, wherein the processor is configured to move the electrode by a first movement to define a first surface on a first side of a tissue volume, and to move the electrode by a second movement to define a second surface on a second side of a tissue volume.

[0239] Clause 76. The system of Clause 74, wherein the processor is configured to advance the electrode distally to define a first surface on a first side of a tissue volume and pull the electrode proximally to define a second surface on a second side of a tissue volume.

[0240] Clause 77. The system according to Clause 76, wherein a gap extends between the elongated electrode and the support structure, and wherein the size of the gap is set to receive tissue, and wherein, when the electrode is pulled proximally, the tissue extending into the gap is cut.

[0241] Clause 78. The system according to Clause 74, wherein the contact plate includes a first configuration and a second configuration, the first configuration defining a first surface on a first side of a volume of tissue, and the second configuration defining a second surface on a second side of a volume of tissue.

[0242] Clause 79. The system according to Clause 74, wherein the first contact plate includes a first shape profile and a second shape profile, the first shape profile defining a first surface on a first side of a volume of tissue, and the second shape profile defining a second surface on a second side of a volume of tissue.

[0243] Clause 80. The system according to Clause 74, wherein the shape profile includes a thickness profile.

[0244] Clause 81. A system for treating refractive errors of the eye, the system comprising: an elongated electrode for cutting corneal tissue; an electrical energy source operatively coupled to the elongated electrode and configured to supply electrical energy to the electrode; a contact plate configured to engage a portion of the cornea prior to cutting the cornea with the electrode to shape the cornea; and a support structure operatively coupled to the elongated electrode and the plate, the support being configured to move the electrode relative to the plate and cut corneal tissue with the electrode.

[0245] Clause 82. The system according to Clause 81 further includes a translation element operatively coupled to the support structure and the elongated electrode to cut corneal tissue by translation of the electrode.

[0246] Clause 83. The system according to Clause 81, wherein the contact plate includes a first contact plate having a first surface profile and a second contact plate having a second surface profile, the difference between the first surface profile and the second surface profile corresponding to refractive correction of the eye to correct refractive errors of the eye.

[0247] Clause 84. The system according to Clause 81, wherein the contact plate includes a free-form optical surface shaped to correct wavefront aberrations of the eye.

[0248] Clause 85. The system according to Clause 81, wherein the contact plate includes more than one independently adjustable actuator for corneal shaping.

[0249] Clause 86. The system according to Clause 85, wherein the contact plate comprises more than one plate operatively coupled to the independently adjustable actuator for corneal shaping.

[0250] Clause 87. The system according to Clause 86, wherein each of the more than one plate is configured to be driven to a first position and a second position at each of the more than one site, the difference between the first position and the second position corresponding to the shape profile of tissue to be removed from the cornea to improve refractive errors of the eye.

[0251] Clause 88. The system according to Clause 87, wherein the more than one region includes more than one two-dimensional region, and the shape profile includes a three-dimensional tissue resection profile.

[0252] Clause 89. The system according to Clause 85, wherein the more than one actuator comprises at least 10 actuators, and optionally, wherein the more than one actuator comprises at least 16 actuators, and optionally, wherein the more than one actuator comprises at least 42 actuators, and optionally, wherein the more than one actuator comprises at least 100 actuators.

[0253] Clause 90. The system according to Clause 85, wherein the contact plate includes a deformable membrane operatively coupled to the more than one independently adjustable actuator.

[0254] Clause 91. The system according to Clause 85, wherein the contact plate includes a first configuration for forming a first incision with the electrode along a first cutting profile and a second configuration for forming a second incision with the electrode along a second cutting profile, and wherein the difference between the first cutting profile and the second cutting profile corresponds to the shape of a lens body of tissue to be removed from the cornea to treat refractive errors of the eye.

[0255] Clause 92. The system according to Clause 81, wherein the contact plate is configured to correct one or more of the spherical, cylindrical, coma, spherical aberration, or tricleaf shape of the eye.

[0256] Clause 93. The system according to Clause 81 further includes a suction element for engaging tissue when the first translation element moves the electrode to cut the tissue, and holding the tissue in contact with the second translation element in a substantially fixed position.

[0257] Clause 94. The system according to Clause 81 further includes a sterile barrier for placement on the contact plate to keep the eye sterile.

[0258] Clause 95. The system according to Clause 94, wherein the sterile barrier comprises a thin conformal barrier to conform to the shape of the contact plate, the sterile barrier being located between the eye and the contact plate.

[0259] Clause 96. The system according to Clause 94, wherein the sterile barrier includes a peel-and-stick sterile barrier.

[0260] Clause 97. The system according to Clause 81, wherein: the length of the elongated electrode is in the range of about 6 mm to about 12 mm; the electrode comprises a wire in the range of 5 µm to 20 µm in diameter; and wherein the tensioning element is configured to provide tension to the electrode in the range of 100 mN to 500 mN.

[0261] Clause 98. The system according to Clause 81 further includes: a processor operatively coupled to the elongated electrode, the processor being configured with instructions for advancing the electrode distally and pulling the electrode proximally.

[0262] Clause 99. The system according to Clause 98, wherein: the elongated electrode is sized for insertion into the cornea of ​​the eye to treat refractive errors of the eye; the processor is configured with instructions to cut the cornea with the electrode to define a lens body of corneal tissue within a pouch; and wherein the lens body includes a shape profile corresponding to the treatment of refractive errors.

[0263] Clause 100. The system according to Clause 99, wherein the processor is configured to move the electrode by a first movement to define a first surface on a first side of the lens body, and to move the electrode by a second movement to define a second surface on a second side of the lens body.

[0264] Clause 101. The system according to Clause 99, wherein the processor is configured with instructions to advance the electrode distally to define a first surface on a first side of the lens body and to pull the electrode proximally to define a second surface on a second side of the lens body.

[0265] Clause 102. The system according to Clause 101, wherein a gap extends between the elongated electrode and the support structure, and wherein the size of the gap is set to receive tissue, and wherein tissue extending into the gap is cut when the electrode is pulled proximally.

[0266] Clause 103. The system according to Clause 99, wherein the contact plate includes a first configuration and a second configuration, the first configuration defining a first surface on a first side of the lens body, and the second configuration defining a second surface on a second side of the lens body.

[0267] Clause 104. The system according to Clause 99, wherein the first contact plate includes a first shape profile and a second shape profile, the first shape profile defining a first surface on a first side of the lens body, and the second shape profile defining a second surface on a second side of the lens body.

[0268] Clause 105. The system according to Clause 99, wherein the shape profile includes a thickness profile.

[0269] Clause 106. A method of cutting tissue with plasma, comprising: cutting tissue with an elongated electrode configured to flex and generate plasma to cut the tissue; wherein an electrical energy source is operatively coupled to the elongated electrode and supplies electrical energy to the electrode to generate the plasma; and wherein a tensioning element is operatively coupled to the elongated electrode and supplies tension to the elongated electrode to allow the elongated electrode to flex in response to the elongated electrode engaging tissue and generating the plasma.

[0270] Clause 107. The method according to Clause 106, wherein more than one arm is operatively coupled to the electrode and the tensioning element.

[0271] Clause 108. The method according to Clause 107, wherein the electrode is unsupported between the two arms.

[0272] Clause 109. The method according to Clause 107, wherein the electrode is configured to vibrate transversely to an axis of extension of the electrode.

[0273] Clause 110. The method according to Clause 107, wherein a support structure is operatively coupled to the more than one arm and the tensioning element, wherein the support structure advances the more than one arm, the tensioning element and the elongated electrode to cut tissue.

[0274] Clause 111. The method according to Clause 110, wherein the cut portion of the elongated electrode is suspended between the more than one arm under tension from the tensioning element, and wherein the gap extends between the more than one arm.

[0275] Clause 112. The method according to Clause 111, wherein the gap extends between the cut portion of the elongated electrode, the more than one arm, and the support structure.

[0276] Clause 113. The method according to Clause 111, wherein the size of the gap is set to receive the cut tissue along the incision formed through the elongated electrode.

[0277] Clause 114. The method according to Clause 110, wherein the support structure is operatively coupled to one or more actuators to move the elongated electrode in one or more directions.

[0278] Clause 115. The method according to Clause 114, wherein the one or more actuators move the electrode at a variable speed.

[0279] Clause 116. The method according to Clause 106, wherein the tensioning element is selected from springs, coil springs, leaf springs, torsion springs, mesh structures, hinges, and movable hinges.

[0280] Clause 117. The method according to Clause 106, wherein the elongated electrode comprises a first portion of an elongated filament, and wherein the tensioning element comprises a second portion of the elongated filament, the second portion being shaped to tension the elongated electrode.

[0281] Clause 118. The method according to Clause 106, comprising an electrode assembly of a support structure operatively coupled to more than one arm and the tensioning element, wherein the electrode assembly advances the electrode into the tissue to cut the tissue.

[0282] Clause 119. The method according to Clause 106, wherein the electrodes sequentially contact more than one site of tissue to create an incision.

[0283] Clause 120. The method according to Clause 119, wherein the more than one part includes more than one discontinuous part.

[0284] Clause 121. The method according to Clause 120, wherein the electrode vaporizes tissue in contact with the electrode at each of the more than one discontinuous site.

[0285] Clause 122. The method according to Clause 106, wherein when the electrode cuts tissue, the electrode generates more than one flash of light at more than one location.

[0286] Clause 123. The method according to Clause 122, wherein the more than one light energy flash includes visible light energy, the visible light energy including wavelengths in the range of about 400 nm to about 750 nm.

[0287] Clause 124. The method according to Clause 122, wherein each of the more than one light flash includes a maximum span of not more than about 1 mm.

[0288] Clause 125. The method according to Clause 122, wherein the more than one flash is generated within a time interval not exceeding about 250 µs and optionally not exceeding about 25 µs.

[0289] Clause 126. The method according to Clause 122, wherein the more than one flash is generated with an electrode movement distance not exceeding about 100 µm and optionally not exceeding about 10 µm.

[0290] Clause 127. The method according to Clause 122, wherein the more than one flash is distributed in more than one non-overlapping region.

[0291] Clause 128. The method according to Clause 127, wherein the more than one non-overlapping region is positioned along the elongated electrode.

[0292] Clause 129. The method according to Clause 122, wherein the more than one flash is generated at a first rate at a first speed of the electrode and at a second rate at a second speed of the electrode, wherein the first rate is greater than the second rate when the first speed is less than the second speed, and wherein the first rate is less than the second rate when the first speed is greater than the second speed.

[0293] Clause 130. The method according to Clause 129, wherein the more than one flash is generated at a substantially constant rate of about 25%, and wherein one or more of the pulse rate or pulse train rate of the waveform applied to the elongated electrode is changed in response to the changing rate of the electrode to maintain the substantially constant rate.

[0294] Clause 131. The method according to Clause 106, wherein the elongated electrode comprises a filament, and wherein the filament comprises one or more wires or strands.

[0295] Clause 132. The method according to Clause 106, wherein the elongated electrode comprises a wire.

[0296] Clause 133. The method according to Clause 132, wherein the diameter of said wire is in the range of 5µm to 200µm, optionally in the range of about 5µm to about 100µm, optionally in the range of about 5µm to about 50µm, optionally in the range of about 5µm to about 25µm, or optionally in the range of about 5µm to about 20µm.

[0297] Clause 134. The method according to Clause 106, wherein the elongated electrode includes a cross-sectional distance, and wherein the cross-sectional distance includes no more than about 25 µm.

[0298] Clause 135. The method according to Clause 106, wherein the elongated electrode operatively coupled to the tensioning element comprises a mechanical resonant frequency in the range of about 1 kHz to about 100 kHz and optionally in the range of about 2 kHz to about 50 kHz.

[0299] Clause 136. The method according to Clause 106, wherein the tensioning element tensions the elongated electrode with a force in the range of about 20 mN to about 2 N, and optionally in the range of about 50 mN to about 1 N, and further optionally in the range of about 100 mN to about 500 mN.

[0300] Clause 137. The method according to Clause 106, wherein the elongated electrode comprises approximately 0.2 µg·mm -1 Approximately 3µg•mm -1 The mass per unit length within the range.

[0301] Clause 138. The method according to Clause 106, wherein the elongated electrode comprises a material selected from the group consisting of tungsten, nickelinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver and aluminum.

[0302] Clause 139. The method according to Clause 106, wherein the elongated electrode includes an axis along the elongation direction of the electrode, and wherein the electrode is moved in a direction transverse to the axis to cut tissue.

[0303] Clause 140. The method according to Clause 106, wherein the elongated electrode moves at a speed greater than about 1 m·s in a direction transverse to the elongation direction of the electrode. -1 It cuts tissue at a speed that allows it to do so.

[0304] Clause 141. The method according to Clause 106, wherein the elongated electrode extends at approximately 0.5 cm·s in a direction transverse to the elongation direction of the electrode. -1 Approximately 10 cm•s -1 Within the range and optionally about 1 cm•s -1 Approximately 5 cm•s -1 It can cut tissue at speeds within a certain range.

[0305] Clause 142. The method according to Clause 106, wherein the electrode is at approximately 5 mm 2 •s -1 Approximately 50,000 mm 2 •s -1 Within the range and optionally approximately 500mm 2 •s -1 Approximately 25,000 mm 2 •s -1 The area of ​​tissue cut at a rate within the specified range.

[0306] Clause 143. The method according to Clause 106, wherein the electrical energy transmission waveform includes one or more of a pulsating waveform, a sine waveform, a square wave waveform, a sawtooth waveform, a triangular wave waveform, a fixed frequency waveform, a variable frequency waveform, or a gated waveform.

[0307] Clause 144. The method according to Clause 143, wherein the waveform includes the sine waveform, and wherein the sine waveform includes frequencies in the range of about 0.5 MHz to about 2 MHz.

[0308] Clause 145. The method according to Clause 143, wherein the waveform comprises a combination of the sine waveform and the gating waveform, wherein the sine waveform comprises a frequency in the range of about 0.5 MHz to about 2 MHz, and wherein the gating waveform comprises a gating frequency in the range of about 20 kHz to about 80 kHz and a duty cycle in the range of about 35% to about 100%.

[0309] Clause 146. The method according to Clause 106, wherein the controller is operatively coupled to the electrical energy source.

[0310] Clause 147. The method according to Clause 146, wherein the controller controls the parameters of the electrical energy source by modulating the waveform using parameters selected from the group consisting of voltage, current, carrier frequency, modulation frequency, duty cycle, power setpoint, power limit, per-pulse energy setpoint, per-pulse energy limit, and modulation envelope.

[0311] Clause 148. The method according to Clause 147, wherein the waveform includes a pulsating voltage waveform comprising pulses and a substantially constant frequency in the range of about 10 kHz to about 10 MHz and optionally in the range of about 0.5 MHz to about 2 MHz.

[0312] Clause 149. The method according to Clause 148, wherein the waveform provides per-pulse energy in the range of about 0.5 µJ to about 50 µJ, and optionally in the range of about 1 µJ to about 10 µJ.

[0313] Clause 150. The method according to Clause 149, wherein the controller modulates the waveform of the substantially constant frequency to generate a pulse train.

[0314] Clause 151. The method according to Clause 150, wherein the frequency of said pulse train is in the range of about 100 Hz to about 3 MHz, and optionally in the range of about 1 kHz to about 100 kHz.

[0315] Clause 152. The method according to Clause 150, wherein the waveform from the electrical energy source provides an average power in the range of about 1W to about 25W.

[0316] Clause 153. The method according to Clause 110, wherein a translational element operatively coupled to the support structure guides the support structure along a motion axis transverse to the elongation axis of the electrode.

[0317] Clause 154. The method according to Clause 153, wherein the translation element is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a guide rail, a rod, a cylindrical sleeve, a lead screw, a roller lead screw, a moving nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a wedge tenon.

[0318] Clause 155. The method according to Clause 154, wherein an actuator operatively coupled to the translation element moves the support structure along a motion axis.

[0319] Clause 156. The method according to Clause 155, wherein the translation element is manually actuated.

[0320] Clause 157. The method according to Clause 155, wherein the actuator is selected from the group consisting of a motor, a rotary motor, a kinetic motor, a linear motor, a solenoid, a rotary solenoid, a linear solenoid, a voice coil, a spring, a moving coil, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, and a jet actuator.

[0321] Clause 158. The method according to Clause 110, wherein a portion of the support structure comprises a material selected from the group consisting of tungsten, nickelitan, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactide, polyoxymethylene, polyetheretherketone, polyvinyl chloride, polylactic acid, glass, and ceramics.

[0322] Clause 159. The method according to Clause 153, wherein the translation element comprises a first translation element having a first axis of motion and a second translation element having a second axis of motion different from the first axis of motion.

[0323] Clause 160. The method according to Clause 159, wherein the first translation element and the second translation element are respectively selected from the group consisting of a free translation stage, a linear stage, a rotary stage, a guide rail, a rod, a cylindrical sleeve, a lead screw, a roller lead screw, a moving nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a wedge tenon.

[0324] Clause 161. The method according to Clause 160, wherein a contact plate operably coupled to the second translation element engages a portion of the tissue prior to cutting the tissue with the electrode to shape the tissue.

[0325] Clause 162. The method according to Clause 106, wherein a contact plate operably coupled to the elongated electrode engages a portion of the cornea prior to cutting the cornea with the electrode to shaped the cornea.

[0326] Clause 163. The method according to Clause 162, wherein the contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, the difference between the first surface profile and the second surface profile corresponding to refractive correction of the eye to correct refractive errors of the eye.

[0327] Clause 164. The method according to Clause 162, wherein the contact plate comprises a free-form optical surface shaped to correct wavefront aberrations of the eye.

[0328] Clause 165. The method according to Clause 162, wherein the contact plate includes more than one independently adjustable actuator for corneal shaping.

[0329] Clause 166. The method according to Clause 165, wherein the contact plate comprises more than one plate operatively coupled to the independently adjustable actuator for corneal shaping.

[0330] Clause 167. The method according to Clause 166, wherein each of the more than one plate is driven to a first position and a second position at each of the more than one site, the difference between the first position and the second position corresponding to the shape profile of tissue to be removed from the cornea to improve refractive errors of the eye.

[0331] Clause 168. The method according to Clause 167, wherein the more than one site includes more than one two-dimensional site, and the shape profile includes a three-dimensional tissue resection profile.

[0332] Clause 169. The method according to Clause 165, wherein the more than one actuator comprises at least 10 actuators, and optionally, wherein the more than one actuator comprises at least 16 actuators, and optionally, wherein the more than one actuator comprises at least 42 actuators, and optionally, wherein the more than one actuator comprises at least 100 actuators.

[0333] Clause 170. The method according to Clause 165, wherein the contact plate includes a deformable membrane operatively coupled to the more than one independently adjustable actuator.

[0334] Clause 171. The method according to Clause 165, wherein the contact plate includes a first configuration and a second configuration, the first configuration for forming a first incision with the electrode along a first cutting profile, the second configuration for forming a second incision with the electrode along a second cutting profile, and wherein the difference between the first cutting profile and the second cutting profile corresponds to the shape of a lens body of tissue removed from the cornea, for treating refractive errors of the eye.

[0335] Clause 172. The method according to Clause 162, wherein the contact plate is configured to correct one or more of the spherical, cylindrical, coma, spherical aberration, or trefoil aberration of the eye.

[0336] Clause 173. The method according to Clause 162, wherein when the first translation element moves the electrode to cut the tissue, the suction element engages the tissue, holding the tissue in contact with the second translation element in a substantially fixed position.

[0337] Clause 174. The method according to Clause 162, wherein a sterile barrier is placed on the contact plate to keep the eye sterile.

[0338] Clause 175. The method according to Clause 174, wherein the sterile barrier comprises a thin conformal barrier to conform to the shape of the contact plate, the sterile barrier being located between the eye and the contact plate.

[0339] Clause 176. The method according to Clause 174, wherein the sterile barrier includes a peel-and-stick sterile barrier.

[0340] Clause 177. The method according to Clause 162, wherein: the length of the elongated electrode is in the range of about 6 mm to about 12 mm; the tissue includes corneal tissue; the electrode includes a wire in the range of about 5 µm to about 20 µm in diameter; and wherein the tensioning element provides tension to the electrode in the range of about 100 mN to about 500 m.

[0341] Clause 178. A method for treating refractive errors of the eye, the method comprising: cutting corneal tissue with an elongated electrode by supplying electrical energy to the electrode; shaping the cornea by engaging a portion of the cornea with a contact plate prior to cutting the cornea with the electrode; and wherein a support structure moves the electrode relative to the plate and cuts the corneal tissue with the electrode.

[0342] Clause 179. The method according to Clause 178, wherein a translation element operatively coupled to the support structure and the elongated electrode translates the electrode to cut corneal tissue.

[0343] Clause 180. The method according to Clause 178, wherein the contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, the difference between the first surface profile and the second surface profile corresponding to refractive correction of the eye to correct refractive errors of the eye.

[0344] Clause 181. The method according to Clause 178, wherein the contact plate comprises a free-form optical surface shaped to correct wavefront aberrations of the eye.

[0345] Clause 182. The method according to Clause 178, wherein the contact plate includes more than one independently adjustable actuator to perform corneal shaping.

[0346] Clause 183. The method according to Clause 182, wherein the contact plate comprises more than one plate operatively coupled to the independently adjustable actuator for corneal shaping.

[0347] Clause 184. The method according to Clause 183, wherein each of the more than one plate is configured to be driven to a first position and a second position at each of the more than one site, the difference between the first position and the second position corresponding to the shape profile of tissue to be removed from the cornea to improve refractive errors of the eye.

[0348] Clause 185. The method according to Clause 184, wherein the more than one site includes more than one two-dimensional site, and the shape profile includes a three-dimensional tissue resection profile.

[0349] Clause 186. The method according to Clause 182, wherein the more than one actuator comprises at least 10 actuators, and optionally, wherein the more than one actuator comprises at least 16 actuators, and optionally, wherein the more than one actuator comprises at least 42 actuators, and optionally, wherein the more than one actuator comprises at least 100 actuators.

[0350] Clause 187. The method according to Clause 182, wherein the contact plate includes a deformable membrane operatively coupled to the more than one independently adjustable actuator.

[0351] Clause 188. The method according to Clause 182, wherein the contact plate includes a first configuration for forming a first incision with the electrode along a first cutting profile and a second configuration for forming a second incision with the electrode along a second cutting profile, and wherein the difference between the first cutting profile and the second cutting profile corresponds to the shape of a lens body of tissue to be removed from the cornea to treat refractive errors of the eye.

[0352] Clause 189. The method according to Clause 178, wherein the contact plate is configured to correct one or more of the spherical, cylindrical, coma, spherical aberration, or trefoil aberration of the eye.

[0353] Clause 190. The method according to Clause 178, wherein when the first translation element moves the electrode to cut tissue, the suction element engages the corneal tissue, holding the corneal tissue in contact with the second translation element in a substantially fixed position.

[0354] Clause 191. The method according to Clause 178, wherein a sterile barrier is placed on the contact plate to maintain the sterility of the eye.

[0355] Clause 192. The method according to Clause 191, wherein the sterile barrier comprises a thin conformal barrier to conform to the shape of the contact plate, the sterile barrier being located between the eye and the contact plate.

[0356] Clause 193. The method according to Clause 191, wherein the sterile barrier includes a peel-and-stick sterile barrier.

[0357] Clause 194. The method according to Clause 178, wherein: the length of the elongated electrode is in the range of 6 mm to 12 mm; the electrode comprises a wire in the range of 5 µm to 20 µm in diameter; and wherein the tensioning element provides the electrode with a tension in the range of 100 mN to 500 mN.

[0358] Clause 195. A method for treating refractive errors of the eye, the method comprising: inserting an elongated electrode into the cornea of ​​the eye; cutting the cornea with the electrode to define a lens body of corneal tissue within a pocket; and removing the lens body; wherein the lens body includes a shape profile corresponding to the treatment of the refractive error.

[0359] Clause 196. The method according to Clause 195, wherein the electrode is moved by a first movement to define a first surface on a first side of the lens body, and by a second movement to define a second surface on a second side of the lens body.

[0360] Clause 197. The method according to Clause 195, wherein the electrode is advanced distally to define a first surface on a first side of the lens body and pulled proximally to define a second surface on a second side of the lens body.

[0361] Clause 198. The method according to Clause 197, wherein the gap extends between the elongated electrode and the support structure, and wherein the size of the gap is set to receive tissue, and wherein tissue extending into the gap is cut when the electrode is pulled proximally.

[0362] Clause 199. The method according to Clause 195, wherein the contact plate includes a first configuration and a second configuration, the first configuration defining a first surface on a first side of the lens body, and the second configuration defining a second surface on a second side of the lens body.

[0363] Clause 200. The method according to Clause 195, wherein the first contact plate includes a first shape profile and a second shape profile, the first shape profile defining a first surface on a first side of the lens body, and the second shape profile defining a second surface on a second side of the lens body.

[0364] Clause 201. The method according to Clause 195, wherein the shape profile includes a thickness profile.

[0365] Clause 202. The system or method according to any one of the preceding clauses further includes: a processor operatively coupled to the elongated electrode to move the elongated electrode to cut tissue.

[0366] Embodiments of this disclosure have been shown and described herein and are provided by way of example only. Many modifications, changes, variations, and substitutions will be recognized by those skilled in the art without departing from the scope of this disclosure. Several alternatives and combinations of the embodiments disclosed herein may be used without departing from the scope of this disclosure and the invention. Therefore, the scope of the invention is defined only by the scope of the appended claims and their equivalents.

Claims

1. A system for cutting tissue with plasma, comprising: An elongated electrode, configured to flex and generate the plasma to cut tissue; An electrical energy source, operably coupled to the elongated electrode and configured to supply electrical energy to the elongated electrode to generate the plasma; Tensioning elements, operably coupled to the elongated electrode, are configured to provide tension to the elongated electrode to allow the elongated electrode to flex in response to the elongated electrode engaging tissue and generating the plasma. and A contact plate operatively coupled to the elongated electrode, the contact plate being configured to engage a portion of the cornea prior to cutting the cornea with the elongated electrode, thereby shaping the cornea.

2. The system of claim 1 further includes more than one arm operatively connected to the elongated electrode and the tensioning element.

3. The system according to claim 2, wherein, The elongated electrode is unsupported between the two arms.

4. The system according to claim 2, wherein, The elongated electrode is configured to vibrate transversely to the axis of its elongation.

5. The system of claim 2, further comprising a support structure operatively coupled to the more than one arm and the tensioning element, wherein the support structure is configured to advance the more than one arm and the tensioning element to advance the elongated electrode into the tissue to cut the tissue.

6. The system according to claim 5, wherein, The cut portion of the elongated electrode is suspended between the more than one arm under tension from the tensioning element, and wherein the gap extends between the more than one arm.

7. The system according to claim 6, wherein, The gap extends between the cut portion of the elongated electrode, the more than one arm, and the support structure.

8. The system according to claim 6, wherein, The size of the gap is set to receive the cut tissue along the incision formed by the elongated electrode.

9. The system according to claim 5, wherein, The support structure is operatively coupled to one or more actuators to move the elongated electrode in one or more directions.

10. The system according to claim 9, wherein, The one or more actuators are configured to move the elongated electrode at a variable speed.

11. The system according to claim 1, wherein, The tensioning element is selected from one or more of a spring and a hinge.

12. The system according to claim 11, wherein, The spring includes a helical spring, a leaf spring, a torsion spring, and / or, wherein the hinge includes a movable hinge.

13. The system according to claim 1, wherein, The tensioning element includes a mesh structure.

14. The system according to claim 1, wherein, The elongated electrode includes a first portion of an elongated filament, and the tensioning element includes a second portion of the elongated filament, the second portion being shaped to tension the elongated electrode.

15. The system of claim 2, further comprising an electrode assembly including a support structure operatively coupled to the more than one arm and the tensioning element, wherein the electrode assembly is configured to advance the elongated electrode into tissue to cut the tissue.

16. The system according to claim 1, wherein, The elongated electrodes are configured to sequentially contact more than one site of tissue to create an incision.

17. The system according to claim 16, wherein, The term "more than one location" includes more than one discontinuous location.

18. The system according to claim 17, wherein, The elongated electrode is configured to vaporize tissue in contact with the elongated electrode at each of the more than one discontinuous site.

19. The system according to claim 1, wherein, The elongated electrode is configured to generate more than one flash of light at more than one location when the elongated electrode cuts the tissue.

20. The system according to claim 19, wherein, The more than one light flash includes visible light energy, which includes wavelengths in the range of about 400 nm to about 750 nm.

21. The system according to claim 19, wherein, Each of the more than one light energy flash includes a maximum span of no more than 1 mm.

22. The system according to claim 19, wherein, The more than one light flash is generated within a time interval of no more than 250µs.

23. The system according to claim 19, wherein, The more than one light flash is generated within a time interval of no more than 25µs.

24. The system according to claim 19, wherein, The more than one light flash is generated with an electrode movement distance not exceeding 100µm.

25. The system according to claim 19, wherein, The more than one light flash is generated with an electrode movement distance of no more than 10µm.

26. The system according to claim 19, wherein, The more than one light energy flash is distributed in more than one non-overlapping region.

27. The system according to claim 26, wherein, The more than one non-overlapping region is positioned along the elongated electrode.

28. The system according to claim 19, wherein, The more than one light flash is generated at a first rate at a first speed of the elongated electrode and at a second rate at a second speed of the elongated electrode, wherein when the first speed is less than the second speed, the first rate is greater than the second rate, and wherein when the first speed is greater than the second speed, the first rate is less than the second rate.

29. The system according to claim 28, wherein, The more than one light energy flash is generated at a substantially constant rate of up to 25%, and wherein one or more of the pulse rate or pulse train rate of the waveform applied to the elongated electrode is changed in response to the rate of change of the elongated electrode to maintain the substantially constant rate.

30. The system according to claim 1, wherein, The elongated electrode includes a filament, and wherein the filament comprises a wire.

31. The system according to claim 30, wherein, The line includes wire.

32. The system according to claim 1, wherein, The elongated electrode comprises wire.

33. The system according to claim 32, wherein, The diameter of the wire is in the range of 5µm to 200µm.

34. The system according to claim 32, wherein, The diameter of the wire is in the range of about 5µm to about 100µm.

35. The system according to claim 32, wherein, The diameter of the wire is in the range of about 5µm to about 50µm.

36. The system according to claim 32, wherein, The diameter of the wire is in the range of about 5µm to about 25µm.

37. The system according to claim 32, wherein, The diameter of the wire is in the range of about 5µm to about 20µm.

38. The system according to claim 1, wherein, The elongated electrode includes a cross-sectional distance, wherein the cross-sectional distance does not exceed 25µm.

39. The system according to claim 1, wherein, The elongated electrode operably coupled to the tensioning element includes a mechanical resonant frequency in the range of about 1 kHz to about 100 kHz.

40. The system according to claim 1, wherein, The elongated electrode operably coupled to the tensioning element includes a mechanical resonant frequency in the range of about 2 kHz to about 50 kHz.

41. The system according to claim 1, wherein, The tensioning element is configured to tension the elongated electrode with a force ranging from about 20 mN to about 2 N.

42. The system according to claim 1, wherein, The tensioning element is configured to tension the elongated electrode with a force ranging from about 50 mN to about 1 N.

43. The system according to claim 1, wherein, The tensioning element is configured to tension the elongated electrode with a force ranging from about 100 mN to about 500 mN.

44. The system according to claim 1, wherein, The elongated electrode comprises approximately 0.2 µg•mm -1 Approximately 3µg•mm -1 The mass per unit length within the range.

45. The system according to claim 1, wherein, The elongated electrode comprises a material selected from one or more of the group consisting of tungsten, nickelinol, steel, copper, titanium, palladium, platinum, platinum-iridium, silver, and aluminum.

46. ​​The system according to claim 45, wherein, The steel includes stainless steel, and / or the copper includes brass, beryllium-copper alloys, and cupronickel alloys.

47. The system according to claim 1, wherein, The elongated electrode includes an axis along the elongation direction of the elongated electrode, and wherein the elongated electrode is configured to move in a direction transverse to the axis to cut tissue.

48. The system according to claim 1, wherein, The elongated electrode is configured to extend at a speed greater than 1 m·s in a direction transverse to the elongation direction of the elongated electrode. -1 It cuts tissue at a speed that allows it to do so.

49. The system according to claim 1, wherein, The elongated electrode is configured to extend at approximately 0.5 cm·s in a direction transverse to the elongation direction of the elongated electrode. -1 Approximately 10 cm•s -1 It can cut tissue at speeds within a certain range.

50. The system according to claim 1, wherein, The elongated electrode is configured to extend at approximately 1 cm·s in a direction transverse to the elongation direction of the elongated electrode. -1 Approximately 5 cm•s -1 It can cut tissue at speeds within a certain range.

51. The system according to claim 1, wherein, The elongated electrode is configured to be approximately 5 mm 2 •s -1 Approximately 50,000 mm 2 •s -1 The area of ​​tissue cut at a rate within the specified range.

52. The system according to claim 1, wherein, The elongated electrode is configured at approximately 500 mm. 2 •s -1 Approximately 25,000 mm 2 •s -1 The area of ​​tissue cut at a rate within the specified range.

53. The system according to claim 1, wherein, The electrical energy is configured to transmit a waveform, wherein the waveform includes one or more of a pulsating waveform, a fixed-frequency waveform, a variable-frequency waveform, or a gated waveform.

54. The system according to claim 53, wherein, The pulsating waveforms include sine waves, square waves, sawtooth waves, and triangular waves.

55. The system according to claim 53, wherein, The waveform includes a sine wave, and wherein, The sine wave includes frequencies in the range of approximately 0.5 MHz to approximately 2 MHz.

56. The system according to claim 53, wherein, The waveform includes a combination of a sine waveform and the gating waveform, wherein the sine waveform includes a frequency in the range of about 0.5 MHz to about 2 MHz, and wherein the gating waveform includes a gating frequency in the range of about 20 kHz to about 80 kHz and a duty cycle in the range of about 35% to about 100%.

57. The system of claim 1 further includes a controller operatively connected to the electrical energy source.

58. The system according to claim 57, wherein, The controller is configured to control the parameters of the electrical energy source by modulating the waveform using parameters selected from one or more of the following groups: voltage, current, carrier frequency, modulation frequency, duty cycle, power setpoint, power limit, per-pulse energy setpoint, per-pulse energy limit, and modulation envelope.

59. The system according to claim 58, wherein, The waveform includes a pulsating voltage waveform, which comprises pulses and a generally constant frequency in the range of about 10 kHz to about 10 MHz.

60. The system according to claim 58, wherein, The waveform includes a pulsating voltage waveform, which comprises pulses and a generally constant frequency in the range of about 0.5 MHz to about 2 MHz.

61. The system according to claim 59, wherein, The waveform provides per-pulse energy in the range of about 0.5µJ to about 50µJ.

62. The system according to claim 59, wherein, The waveform provides per-pulse energy in the range of approximately 1 µJ to approximately 10 µJ.

63. The system according to claim 61, wherein, The controller is configured to modulate the generally constant frequency waveform to generate a pulse train.

64. The system according to claim 63, wherein, The frequency of the pulse train is in the range of approximately 100 Hz to approximately 3 MHz.

65. The system according to claim 63, wherein, The frequency of the pulse train is in the range of about 1 kHz to about 100 kHz.

66. The system according to claim 64, wherein, The waveform from the electrical energy source is configured to provide an average power in the range of about 1W to about 25W.

67. The system of claim 5 further includes a translation element operably coupled to the support structure and configured to guide the support structure along a motion axis transverse to the elongation axis of the elongated electrode.

68. The system according to claim 67, wherein, The translation element is selected from one or more of the following groups: translation stage, linear stage, rotary stage, guide rail, rod, cylindrical sleeve, lead screw, moving nut, rack, pinion, belt, chain, linear motion bearing, rotary motion bearing, cam, flexure, and wedge tenon.

69. The system according to claim 68, wherein, The lead screw includes a roller lead screw.

70. The system of claim 68, further comprising an actuator operably coupled to the translational element to move the support structure along a motion axis.

71. The system according to claim 70, wherein, The translation element is manually actuated.

72. The system according to claim 70, wherein, The actuator is selected from one or more of the following groups: motor, solenoid, spring, moving coil, piezoelectric actuator, pneumatic actuator, hydraulic actuator, and jet actuator.

73. The system according to claim 72, wherein, The motor includes a rotary motor, a linear motor, and / or, wherein the solenoid includes a rotary solenoid, a linear solenoid, and / or, the moving coil includes a voice coil.

74. The system according to claim 73, wherein, The linear motor includes a peristaltic piezoelectric linear motor.

75. The system according to claim 5, wherein, A portion of the support structure comprises a material selected from one or more of the group consisting of tungsten, nickelinol, steel, copper, titanium, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactide, polyoxymethylene, polyetheretherketone, polyvinyl chloride, polylactic acid, glass, and ceramics.

76. The system according to claim 75, wherein, The steel includes stainless steel, and / or the copper includes brass, beryllium-copper alloys, and cupronickel alloys.

77. The system according to claim 67, wherein, The translation element includes a first translation element having a first axis of motion and a second translation element having a second axis of motion different from the first axis of motion.

78. The system according to claim 77, wherein, The first translation element and the second translation element are respectively selected from one or more of the following groups: free translation stage, linear stage, rotary stage, guide rail, rod, cylindrical sleeve, lead screw, moving nut, rack, pinion, belt, chain, linear motion bearing, rotary motion bearing, cam, flexure and wedge tenon.

79. The system according to claim 78, wherein, The lead screw includes a roller lead screw.

80. The system according to claim 78, wherein, The contact plate is operatively coupled to the second translational element to engage a portion of the tissue before it is cut with the elongated electrode, thereby shaping the tissue.

81. The system according to claim 1, wherein, The contact plate includes a first contact plate having a first surface profile and a second contact plate having a second surface profile, the difference between the first surface profile and the second surface profile corresponding to the refractive correction of the eye to correct the refractive error of the eye.

82. The system according to claim 1, wherein, The contact plate includes a free-form optical surface shaped to correct wavefront aberrations of the eye.

83. The system according to claim 1, wherein, The contact plate includes more than one independently adjustable actuator to shape the cornea.

84. The system according to claim 83, wherein, The contact plate includes more than one plate operatively coupled to the independently adjustable actuator to perform corneal shaping.

85. The system according to claim 84, wherein, Each of the more than one plate is configured to be driven to a first position and a second position at each of the more than one site, the difference between the first position and the second position corresponding to the shape profile of the tissue to be removed from the cornea to improve the refractive error of the eye.

86. The system according to claim 85, wherein, The more than one site includes more than one two-dimensional site, and the shape profile includes a three-dimensional tissue resection profile.

87. The system according to claim 83, wherein, The more than one independently adjustable actuator includes at least 10 actuators.

88. The system according to claim 83, wherein, The more than one independently adjustable actuator includes at least 16 actuators.

89. The system according to claim 83, wherein, The more than one independently adjustable actuator includes at least 42 actuators.

90. The system according to claim 83, wherein, The more than one independently adjustable actuator includes at least 100 actuators.

91. The system according to claim 83, wherein, The contact plate includes a deformable membrane operatively coupled to the more than one independently adjustable actuator.

92. The system according to claim 83, wherein, The contact plate includes a first configuration for forming a first incision with the elongated electrode along a first cutting contour and a second configuration for forming a second incision with the elongated electrode along a second cutting contour, wherein the difference between the first cutting contour and the second cutting contour corresponds to the shape of a lens body of tissue to be removed from the cornea to treat refractive errors of the eye.

93. The system according to claim 1, wherein, The contact plate is configured to correct one or more of the eye’s spherical, cylindrical, coma, spherical aberration, or trefoil shape.

94. The system of claim 77 further includes a suction element for engaging tissue when the first translation element moves the elongated electrode to cut tissue, and holding the tissue in contact with the second translation element in a substantially fixed position.

95. The system of claim 1 further includes a sterile barrier for placement on a contact plate to keep the eye sterile.

96. The system according to claim 95, wherein, The sterile barrier includes a thin, conformal barrier that conforms to the shape of the contact plate, the sterile barrier being located between the eye and the contact plate.

97. The system according to claim 95, wherein, The sterile barrier includes a peel-and-stick sterile barrier.

98. The system according to claim 1, wherein: The length of the elongated electrode is in the range of approximately 6 mm to approximately 12 mm; The tissue includes corneal tissue; The elongated electrode comprises wires with diameters ranging from approximately 5 µm to approximately 20 µm; and The tensioning element is configured to provide tension to the elongated electrode in the range of about 100 mN to about 500 mN.

99. The system according to claim 1, further comprising: A processor operatively coupled to the elongated electrode, the processor being configured with instructions for advancing the elongated electrode distally and pulling the elongated electrode proximally.

100. The system according to claim 99, wherein: The elongated electrode is sized for insertion into tissue; The processor is configured with instructions to cut tissue using the elongated electrode to define the volume of the cut tissue; and The volume includes a shape profile.

101. The system according to claim 100, wherein, The processor is configured with instructions to move the elongated electrode by a first movement to define a first surface on a first side of the tissue volume, and to move the elongated electrode by a second movement to define a second surface on a second side of the tissue volume.

102. The system according to claim 100, wherein, The processor is configured with instructions to advance the elongated electrode distally to define a first surface on a first side of a tissue volume, and to pull the elongated electrode proximally to define a second surface on a second side of a tissue volume.

103. The system according to claim 5, wherein, The gap extends between the elongated electrode and the support structure, and wherein the size of the gap is set to receive tissue, and wherein, when the elongated electrode is pulled proximally, the tissue extending into the gap is cut.

104. The system of claim 100, wherein the contact plate comprises a first configuration and a second configuration, the first configuration defining a first surface on a first side of a volume of tissue, and the second configuration defining a second surface on a second side of a volume of tissue.

105. The system according to claim 100, wherein, The first contact plate includes a first shape profile and a second shape profile, the first shape profile defining a first surface on a first side of the tissue volume, and the second shape profile defining a second surface on a second side of the tissue volume.

106. The system according to claim 100, wherein, The shape profile includes a thickness profile.

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